Manufacturer's Devices - Siemens Healthcare Diagnostics Inc

Address:




511 Benedict Avenue



Tarrytown

NY 10591

United States


Authorised Representative/ UK Responsible Person
Name: Siemens Healthcare Diagnostics Limited
Address:

Park View Watchmoor Park



Surrey

Camberley GU15 3YL

England United Kingdom



Code/Term Type
Hepatitis B virus core total antibody IVD kit chemiluminescent immunoassayHepatitis B virus core total antibody IVD kit chemiluminescent immunoassayIVD General
Hepatitis B virus e-antigen IVD kit chemiluminescent immunoassayHepatitis B virus e-antigen IVD kit chemiluminescent immunoassayIVD Annex II List A
Hepatitis B virus e-antigen immunoglobulin G (IgG) antibody IVD controlHepatitis B virus e-antigen immunoglobulin G (IgG) antibody IVD controlIVD Annex II List A
Hepatitis B virus core immunoglobulin M (IgM) antibody IVD kit chemiluminescent immunoassayHepatitis B virus core immunoglobulin M (IgM) antibody IVD kit chemiluminescent immunoassayIVD Annex II List A
HIV1/HIV2 antigen/antibody IVD kit chemiluminescent immunoassayHIV1/HIV2 antigen/antibody IVD kit chemiluminescent immunoassayIVD Annex II List A
Hepatitis B virus surface total antibody IVD controlHepatitis B virus surface total antibody IVD controlIVD Annex II List A
Hepatitis B virus surface total antibody IVD kit chemiluminescent immunoassayHepatitis B virus surface total antibody IVD kit chemiluminescent immunoassayIVD Annex II List A
Hepatitis B virus core total antibody IVD controlHepatitis B virus core total antibody IVD controlIVD Annex II List A
Hepatitis B virus surface antigen IVD controlHepatitis B virus surface antigen IVD controlIVD Annex II List A
Hepatitis B virus surface antigen IVD kit chemiluminescent immunoassayHepatitis B virus surface antigen IVD kit chemiluminescent immunoassayIVD Annex II List A
Hepatitis C virus total antibody IVD controlHepatitis C virus total antibody IVD controlIVD Annex II List A
Hepatitis C virus total antibody IVD kit chemiluminescent assayHepatitis C virus total antibody IVD kit chemiluminescent assayIVD Annex II List A
Hepatitis B virus core immunoglobulin M (IgM) antibody IVD controlHepatitis B virus core immunoglobulin M (IgM) antibody IVD controlIVD Annex II List A
Hepatitis B virus core total antibody IVD kit chemiluminescent immunoassayHepatitis B virus core total antibody IVD kit chemiluminescent immunoassayIVD Annex II List A
HIV1/HIV2 antibody IVD kit chemiluminescent immunoassayHIV1/HIV2 antibody IVD kit chemiluminescent immunoassayIVD Annex II List A
HIV1/HIV2 antibody IVD controlHIV1/HIV2 antibody IVD controlIVD Annex II List A
Hepatitis B virus surface antigen neutralization IVD kit chemiluminescent immunoassayHepatitis B virus surface antigen neutralization IVD kit chemiluminescent immunoassayIVD Annex II List A
HIV1/HIV2 antigen/antibody IVD controlHIV1/HIV2 antigen/antibody IVD controlIVD Annex II List A
Total prostate specific antigen (tPSA) IVD calibratorTotal prostate specific antigen (tPSA) IVD calibratorIVD Annex II List B
Free (unbound) prostate specific antigen (fPSA) IVD kit chemiluminescent immunoassayFree (unbound) prostate specific antigen (fPSA) IVD kit chemiluminescent immunoassayIVD Annex II List B
Rubella virus immunoglobulin G (IgG) antibody IVD controlRubella virus immunoglobulin G (IgG) antibody IVD controlIVD Annex II List B
Total prostate specific antigen (tPSA) IVD kit chemiluminescent immunoassayTotal prostate specific antigen (tPSA) IVD kit chemiluminescent immunoassayIVD Annex II List B
Rubella virus immunoglobulin M (IgM) antibody IVD controlRubella virus immunoglobulin M (IgM) antibody IVD controlIVD Annex II List B
Rubella virus immunoglobulin M (IgM) antibody IVD kit chemiluminescent immunoassayRubella virus immunoglobulin M (IgM) antibody IVD kit chemiluminescent immunoassayIVD Annex II List B
Urine protein IVD kit rapid colorimetric clinicalUrine protein IVD kit rapid colorimetric clinicalIVD Devices for Self-Testing
HIV1 nucleic acid IVD kit nucleic acid technique (NAT)HIV1 nucleic acid IVD kit nucleic acid technique (NAT) Conformity Assessment Certificate ExpiredIVD Annex II List A
HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD kit nucleic acid technique (NAT)HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD kit nucleic acid technique (NAT) Conformity Assessment Certificate ExpiredIVD Annex II List A
Urine blood IVD kit rapid colorimetric clinicalUrine blood IVD kit rapid colorimetric clinical Conformity Assessment Certificate ExpiredIVD Devices for Self-Testing
Hepatitis C virus nucleic acid IVD kit nucleic acid technique (NAT)Hepatitis C virus nucleic acid IVD kit nucleic acid technique (NAT) Conformity Assessment Certificate ExpiredIVD Annex II List A
Rubellavirus immunoglobulin G (IgG) antibody IVD kit chemiluminescent immunoassayRubellavirus immunoglobulin G (IgG) antibody IVD kit chemiluminescent immunoassayIVD Annex II List B
Urine analyser IVD point-of-careUrine analyser IVD point-of-careIVD Devices for Self-Testing
Multichannel clinical chemistry analyser IVD laboratoryMultichannel clinical chemistry analyser IVD laboratoryIVD Devices for Self-Testing
Complexed prostate specific antigen (cPSA) IVD calibratorComplexed prostate specific antigen (cPSA) IVD calibratorIVD Annex II List B
Toxoplasma gondii immunoglobulin M (IgM) antibody IVD controlToxoplasma gondii immunoglobulin M (IgM) antibody IVD controlIVD Annex II List B
Toxoplasma gondii immunoglobulin M (IgM) antibody IVD kit chemiluminescent immunoassayToxoplasma gondii immunoglobulin M (IgM) antibody IVD kit chemiluminescent immunoassayIVD Annex II List B
Complexed prostate specific antigen (cPSA) IVD reagentComplexed prostate specific antigen (cPSA) IVD reagentIVD Annex II List B
Complexed prostate specific antigen (cPSA) IVD kit chemiluminescent immunoassayComplexed prostate specific antigen (cPSA) IVD kit chemiluminescent immunoassayIVD Annex II List B
Free (unbound) prostate specific antigen (fPSA) IVD calibratorFree (unbound) prostate specific antigen (fPSA) IVD calibratorIVD Annex II List B
Toxoplasma gondii immunoglobulin G (IgG) antibody IVD controlToxoplasma gondii immunoglobulin G (IgG) antibody IVD controlIVD Annex II List B
Toxoplasma gondii immunoglobulin G (IgG) antibody IVD kit chemiluminescent immunoassayToxoplasma gondii immunoglobulin G (IgG) antibody IVD kit chemiluminescent immunoassayIVD Annex II List B
Complexed prostate specific antigen (cPSA) IVD controlComplexed prostate specific antigen (cPSA) IVD controlIVD Annex II List B
Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD controlCytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD controlIVD Annex II List B
Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD kit chemiluminescent immunoassayCytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD kit chemiluminescent immunoassayIVD Annex II List B
Cancer antigen 15-3 (CA15-3) IVD calibratorCancer antigen 15-3 (CA15-3) IVD calibratorIVD General
Multiple human hormone IVD calibratorMultiple human hormone IVD calibratorIVD General
Treponema pallidum total antibody IVD controlTreponema pallidum total antibody IVD controlIVD General
Microscope slide maker/stainer IVDMicroscope slide maker/stainer IVDIVD General
Multiple tissue-associated protein/tumour marker IVD calibratorMultiple tissue-associated protein/tumour marker IVD calibratorIVD General
Cancer antigen 125 (CA125) IVD calibratorCancer antigen 125 (CA125) IVD calibratorIVD General
Lipoprotein A IVD calibratorLipoprotein A IVD calibratorIVD General
C-peptide IVD calibratorC-peptide IVD calibratorIVD General
Hepatitis A virus immunoglobulin M (IgM) antibody IVD controlHepatitis A virus immunoglobulin M (IgM) antibody IVD controlIVD General
Hepatitis A virus total antibody IVD controlHepatitis A virus total antibody IVD controlIVD General
Insulin IVD calibratorInsulin IVD calibratorIVD General
Sex hormone binding globulin (SHBG) IVD calibratorSex hormone binding globulin (SHBG) IVD calibratorIVD General
Parathyroid hormone (PTH) IVD calibratorParathyroid hormone (PTH) IVD calibratorIVD General
Parathyroid hormone (PTH) IVD controlParathyroid hormone (PTH) IVD controlIVD General
pH-adjusted buffer solution IVDpH-adjusted buffer solution IVDIVD General
Wright staining solution IVDWright staining solution IVDIVD General
Multiple steroid hormone IVD calibratorMultiple steroid hormone IVD calibratorIVD General
May-Grnwald staining solution IVDMay-Grnwald staining solution IVDIVD General
Dithiothriotol (DTT) reagent IVDDithiothriotol (DTT) reagent IVDIVD General
Allergen-specific/total immunoglobulin E (IgE) antibody IVD calibratorAllergen-specific/total immunoglobulin E (IgE) antibody IVD calibratorIVD General
Creatine kinase myocardial isoenzyme (CKMB) IVD calibratorCreatine kinase myocardial isoenzyme (CKMB) IVD calibratorIVD General
Calcium (Ca2+) IVD kit spectrophotometryCalcium (Ca2+) IVD kit spectrophotometryIVD General
Magnesium (Mg2+) IVD kit spectrophotometryMagnesium (Mg2+) IVD kit spectrophotometryIVD General
B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD kit chemiluminescent immunoassayB-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD kit chemiluminescent immunoassayIVD General
B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD calibratorB-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD calibratorIVD General
B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD controlB-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD controlIVD General
Multiple-type clinical chemistry analyte profile IVD calibratorMultiple-type clinical chemistry analyte profile IVD calibratorIVD General
Hepatitis A virus immunoglobulin M (IgM) antibody IVD kit chemiluminescent immunoassayHepatitis A virus immunoglobulin M (IgM) antibody IVD kit chemiluminescent immunoassayIVD General
Hepatitis A virus total antibody IVD kit chemiluminescent immunoassayHepatitis A virus total antibody IVD kit chemiluminescent immunoassayIVD General
Herpes simplex virus 1 (HSV1) immunoglobulin G (IgG) antibody IVD kit chemiluminescent immunoassayHerpes simplex virus 1 (HSV1) immunoglobulin G (IgG) antibody IVD kit chemiluminescent immunoassayIVD General
Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD kit chemiluminescent immunoassayHerpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD kit chemiluminescent immunoassayIVD General
Nucleic acid extraction/isolation kit IVDNucleic acid extraction/isolation kit IVDIVD General
Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD controlHerpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD controlIVD General
Herpes simplex virus 1 (HSV1) immunoglobulin G (IgG) antibody IVD controlHerpes simplex virus 1 (HSV1) immunoglobulin G (IgG) antibody IVD controlIVD General
Multiple electrolyte IVD calibratorMultiple electrolyte IVD calibratorIVD General
Multiple electrolyte IVD reagentMultiple electrolyte IVD reagentIVD General
Calcium (Ca2+) IVD kit ion-selective electrode (ISE)Calcium (Ca2+) IVD kit ion-selective electrode (ISE)IVD General
Haematological cell analyser IVDHaematological cell analyser IVDIVD General
Erythropoietin (EPO) IVD controlErythropoietin (EPO) IVD controlIVD General
Multiple clinical chemistry enzyme IVD calibratorMultiple clinical chemistry enzyme IVD calibratorIVD General
Alanine aminotransferase (ALT) IVD kit enzyme spectrophotometryAlanine aminotransferase (ALT) IVD kit enzyme spectrophotometryIVD General
Alanine aminotransferase (ALT) IVD reagentAlanine aminotransferase (ALT) IVD reagentIVD General
Total alkaline phosphatase (ALP) IVD kit enzyme spectrophotometryTotal alkaline phosphatase (ALP) IVD kit enzyme spectrophotometryIVD General
Total amylase IVD kit enzyme spectrophotometryTotal amylase IVD kit enzyme spectrophotometryIVD General
Total aspartate aminotransferase (AST) IVD kit enzyme spectrophotometryTotal aspartate aminotransferase (AST) IVD kit enzyme spectrophotometryIVD General
Acetylcholinesterase IVD kit enzyme spectrophotometryAcetylcholinesterase IVD kit enzyme spectrophotometryIVD General
Total creatine kinase (CK) IVD kit enzyme spectrophotometryTotal creatine kinase (CK) IVD kit enzyme spectrophotometryIVD General
Total creatine kinase (CK) IVD calibratorTotal creatine kinase (CK) IVD calibratorIVD General
Gamma-glutamyltransferase (GGT) IVD kit enzyme spectrophotometryGamma-glutamyltransferase (GGT) IVD kit enzyme spectrophotometryIVD General
Total lactate dehydrogenase (LDH) IVD kit enzyme spectrophotometryTotal lactate dehydrogenase (LDH) IVD kit enzyme spectrophotometryIVD General
Lipase IVD kit enzyme spectrophotometryLipase IVD kit enzyme spectrophotometryIVD General
Ammonia IVD kit enzyme spectrophotometryAmmonia IVD kit enzyme spectrophotometryIVD General
Fructosamine IVD kit enzyme spectrophotometryFructosamine IVD kit enzyme spectrophotometryIVD General
Fructosamine IVD calibratorFructosamine IVD calibratorIVD General
Glycated haemoglobin (HbA1c) IVD kit liquid chromatographyGlycated haemoglobin (HbA1c) IVD kit liquid chromatographyIVD Devices for Self-Testing
Glycated haemoglobin (HbA1c) IVD kit liquid chromatographyGlycated haemoglobin (HbA1c) IVD kit liquid chromatographyIVD General
Conjugated (direct) bilirubin IVD kit enzyme spectrophotometryConjugated (direct) bilirubin IVD kit enzyme spectrophotometryIVD General
Creatinine IVD kit spectrophotometryCreatinine IVD kit spectrophotometryIVD General
Glucose IVD kit enzyme spectrophotometryGlucose IVD kit enzyme spectrophotometryIVD General
Glycated haemoglobin (HbA1c) IVD calibratorGlycated haemoglobin (HbA1c) IVD calibratorIVD General
Total cholesterol lipid IVD kit enzyme spectrophotometryTotal cholesterol lipid IVD kit enzyme spectrophotometryIVD General
High density lipoprotein (HDL) cholesterol IVD kit enzyme spectrophotometryHigh density lipoprotein (HDL) cholesterol IVD kit enzyme spectrophotometryIVD General
Low density lipoprotein (LDL) cholesterol IVD kit enzyme spectrophotometryLow density lipoprotein (LDL) cholesterol IVD kit enzyme spectrophotometryIVD General
Lipoprotein A IVD kit nephelometry/turbidimetryLipoprotein A IVD kit nephelometry/turbidimetryIVD General
Haemoglobin/hematocrit analyser IVDHaemoglobin/hematocrit analyser IVDIVD General
Pipette tip IVDPipette tip IVDIVD General
Glycated haemoglobin (HbA1c) IVD kit enzyme spectrophotometryGlycated haemoglobin (HbA1c) IVD kit enzyme spectrophotometryIVD General
Coagulation analyser IVD point-of-care battery-poweredCoagulation analyser IVD point-of-care battery-poweredIVD General
Oxycodone IVD kit enzyme immunoassay (EIA)Oxycodone IVD kit enzyme immunoassay (EIA)IVD General
Capillary blood collection tube IVD electrolyte-balanced heparinCapillary blood collection tube IVD electrolyte-balanced heparinIVD General
Laboratory waste receptacle IVDLaboratory waste receptacle IVDIVD General
Holotranscobalamin (holoTC) IVD kit chemiluminescent immunoassayHolotranscobalamin (holoTC) IVD kit chemiluminescent immunoassayIVD General
N-acetyl procainamide (NAPA) IVD kit nephelometry/turbidimetryN-acetyl procainamide (NAPA) IVD kit nephelometry/turbidimetryIVD General
Procainamide therapeutic drug monitoring IVD kit nephelometry/turbidimetryProcainamide therapeutic drug monitoring IVD kit nephelometry/turbidimetryIVD General
Lidocaine therapeutic drug monitoring IVD kit nephelometry/turbidimetryLidocaine therapeutic drug monitoring IVD kit nephelometry/turbidimetryIVD General
Sodium (Na+) electrode IVDSodium (Na+) electrode IVDIVD General
Nucleic acid sample preparation instrument IVDNucleic acid sample preparation instrument IVDIVD General
Multiple thyroid marker IVD reagentMultiple thyroid marker IVD reagentIVD General
Capillary blood collection tube IVD lithium heparinCapillary blood collection tube IVD lithium heparinIVD General
Reference electrode IVDReference electrode IVDIVD General
Hydrogen (H+)/pH electrode IVDHydrogen (H+)/pH electrode IVDIVD General
Potassium (K+) electrode IVDPotassium (K+) electrode IVDIVD General
Microcapillary blood collection tube IVD no additiveMicrocapillary blood collection tube IVD no additiveIVD General
Ion selective electrode (ISE) reference solution IVD reagentIon selective electrode (ISE) reference solution IVD reagentIVD General
Calcium (Ca2+) electrode IVDCalcium (Ca2+) electrode IVDIVD General
Chloride (Cl-) electrode IVDChloride (Cl-) electrode IVDIVD General
Multiple clinical chemistry analyser IVD laboratoryMultiple clinical chemistry analyser IVD laboratoryIVD General
Prothrombin time (PT) IVD controlProthrombin time (PT) IVD controlIVD General
Prothrombin time (PT) IVD reagentProthrombin time (PT) IVD reagentIVD General
Multiple therapeutic drugs/drugs of abuse IVD calibratorMultiple therapeutic drugs/drugs of abuse IVD calibratorIVD General
Mycophenolate therapeutic drug monitoring IVD kit enzyme immunoassay (EIA)Mycophenolate therapeutic drug monitoring IVD kit enzyme immunoassay (EIA)IVD General
Tacrolimus therapeutic drug monitoring IVD kit enzyme immunoassay (EIA)Tacrolimus therapeutic drug monitoring IVD kit enzyme immunoassay (EIA)IVD General
Rheumatoid factor IVD kit nephelometry/turbidimetryRheumatoid factor IVD kit nephelometry/turbidimetryIVD General
Multiple urine analyte IVD kit rapid colorimetric clinicalMultiple urine analyte IVD kit rapid colorimetric clinicalIVD General
Multiple lipid analyte IVD calibratorMultiple lipid analyte IVD calibratorIVD General
Microalbumin IVD controlMicroalbumin IVD controlIVD General
Procalcitonin (PCT) IVD controlProcalcitonin (PCT) IVD controlIVD General
Microalbumin IVD kit enzyme spectrophotometryMicroalbumin IVD kit enzyme spectrophotometryIVD General
Calcitonin IVD kit chemiluminescent immunoassayCalcitonin IVD kit chemiluminescent immunoassayIVD General
Multiple electrolyte IVD kit ion-selective electrode (ISE)Multiple electrolyte IVD kit ion-selective electrode (ISE)IVD General
Chloride (Cl-) IVD kit ion-selective electrode (ISE)Chloride (Cl-) IVD kit ion-selective electrode (ISE)IVD General
Sodium (Na+) IVD kit ion-selective electrode (ISE)Sodium (Na+) IVD kit ion-selective electrode (ISE)IVD General
Potassium (K+) IVD kit ion-selective electrode (ISE)Potassium (K+) IVD kit ion-selective electrode (ISE)IVD General
Multiple blood gas/haemoximetry/electrolyte analyte IVD reagentMultiple blood gas/haemoximetry/electrolyte analyte IVD reagentIVD General
Multiple blood gas/haemoximetry/electrolyte analyte IVD controlMultiple blood gas/haemoximetry/electrolyte analyte IVD controlIVD General
Albumin IVD calibratorAlbumin IVD calibratorIVD General
Multiple blood gas/haemoximetry/electrolyte analyte IVD calibratorMultiple blood gas/haemoximetry/electrolyte analyte IVD calibratorIVD General
Blood gas syringe IVD sodium heparinBlood gas syringe IVD sodium heparinIVD General
Blood pH electrodeBlood pH electrodeIVD General
Human chorionic gonadotropin beta-core fragment IVD kit rapid ICT clinicalHuman chorionic gonadotropin beta-core fragment IVD kit rapid ICT clinicalIVD General
Giemsa staining solution IVDGiemsa staining solution IVDIVD General
Multiple blood gas analyte IVD calibratorMultiple blood gas analyte IVD calibratorIVD General
Blood gas electrode carbon dioxideBlood gas electrode carbon dioxideIVD General
Blood oxygen electrode IVDBlood oxygen electrode IVDIVD General
Multiple urine analyte IVD controlMultiple urine analyte IVD controlIVD General
Reticulocyte count IVD controlReticulocyte count IVD controlIVD General
Haematological cell analyser IVD semi-automatedHaematological cell analyser IVD semi-automatedIVD General
Lactate electrode IVDLactate electrode IVDIVD General
Theophylline therapeutic drug monitoring IVD kit nephelometry/turbidimetryTheophylline therapeutic drug monitoring IVD kit nephelometry/turbidimetryIVD General
Lipopolysaccharide binding protein (LBP) IVD kit chemiluminescent immunoassayLipopolysaccharide binding protein (LBP) IVD kit chemiluminescent immunoassayIVD General
Lipopolysaccharide binding protein (LBP) IVD controlLipopolysaccharide binding protein (LBP) IVD controlIVD General
Holotranscobalamin (holoTC) IVD controlHolotranscobalamin (holoTC) IVD controlIVD General
FerritinIVD kit chemiluminescent immunoassayFerritinIVD kit chemiluminescent immunoassayIVD General
Cyclic citrullinated peptide antibody (anti-CCP) IVD kit chemiluminescent immunoassayCyclic citrullinated peptide antibody (anti-CCP) IVD kit chemiluminescent immunoassayIVD General
Blood cell lysis reagent IVDBlood cell lysis reagent IVDIVD General
Carbamazepine therapeutic drug monitoring IVD kit nephelometry/turbidimetryCarbamazepine therapeutic drug monitoring IVD kit nephelometry/turbidimetryIVD General
Phenytoin therapeutic drug monitoring IVD kit nephelometry/turbidimetryPhenytoin therapeutic drug monitoring IVD kit nephelometry/turbidimetryIVD General
Vancomycintherapeutic drug monitoring IVD kit chemiluminescent immunoassayVancomycintherapeutic drug monitoring IVD kit chemiluminescent immunoassayIVD General
Vancomycintherapeutic drug monitoring IVD kit enzyme immunoassay (EIA)Vancomycintherapeutic drug monitoring IVD kit enzyme immunoassay (EIA)IVD General
Valproicacidtherapeutic drug monitoring IVD kit chemiluminescent immunoassayValproicacidtherapeutic drug monitoring IVD kit chemiluminescent immunoassayIVD General
Tobramycintherapeutic drug monitoring IVD kit enzyme immunoassay (EIA)Tobramycintherapeutic drug monitoring IVD kit enzyme immunoassay (EIA)IVD General
HomocysteineIVD kit chemiluminescent immunoassayHomocysteineIVD kit chemiluminescent immunoassayIVD General
Gentamicintherapeutic drug monitoring IVD kit chemiluminescent immunoassayGentamicintherapeutic drug monitoring IVD kit chemiluminescent immunoassayIVD General
Laboratory analyser cuvette IVD single-useLaboratory analyser cuvette IVD single-useIVD General
Laboratory analyser cuvette IVD reusableLaboratory analyser cuvette IVD reusableIVD General
Creatinekinasemyocardialisoenzyme (CKMB) IVD kit chemiluminescent immunoassayCreatinekinasemyocardialisoenzyme (CKMB) IVD kit chemiluminescent immunoassayIVD General
Cyclosporin A/cyclosporinetherapeutic drug monitoring IVD kit chemiluminescent immunoassayCyclosporin A/cyclosporinetherapeutic drug monitoring IVD kit chemiluminescent immunoassayIVD General
Tobramycin therapeutic drug monitoring IVD kit nephelometry/turbidimetryTobramycin therapeutic drug monitoring IVD kit nephelometry/turbidimetryIVD General
Vancomycin therapeuticdrug monitoringIVD kitnephelometry/turbidimetryVancomycin therapeuticdrug monitoringIVD kitnephelometry/turbidimetryIVD General
Valproicacidtherapeutic drug monitoring IVD kit nephelometry/turbidimetryValproicacidtherapeutic drug monitoring IVD kit nephelometry/turbidimetryIVD General
Urine analyser IVD point-of-careUrine analyser IVD point-of-careIVD General
Blood gas/haemoximetry analyser IVD point-of-careBlood gas/haemoximetry analyser IVD point-of-careIVD General
Glycated haemoglobin (HbA1C) analyser IVDGlycated haemoglobin (HbA1C) analyser IVDIVD General
Phenytoin therapeutic drug monitoring IVD kit chemiluminescent immunoassayPhenytoin therapeutic drug monitoring IVD kit chemiluminescent immunoassayIVD General
Procollagentype III N-terminal propeptide (PIIINP) IVD kit chemiluminescent immunoassayProcollagentype III N-terminal propeptide (PIIINP) IVD kit chemiluminescent immunoassayIVD General
Theophyllinetherapeutic drug monitoring IVD kit chemiluminescent immunoassayTheophyllinetherapeutic drug monitoring IVD kit chemiluminescent immunoassayIVD General
TricyclicantidepressantIVD kit enzyme immunoassay (EIA)TricyclicantidepressantIVD kit enzyme immunoassay (EIA)IVD General
Multiple liver fibrosis marker IVD controlMultiple liver fibrosis marker IVD controlIVD General
Multiple liver fibrosis marker IVD calibratorMultiple liver fibrosis marker IVD calibratorIVD General
Multiple anaemia-related analyte IVD calibratorMultiple anaemia-related analyte IVD calibratorIVD General
C-erbB2/Her2/neu oncoprotein IVD kit chemiluminescent immunoassayC-erbB2/Her2/neu oncoprotein IVD kit chemiluminescent immunoassayIVD General
Hyaluronic acid (HA) IVD kit chemiluminescent immunoassayHyaluronic acid (HA) IVD kit chemiluminescent immunoassayIVD General
Folate(vitamin B9) IVD kit chemiluminescent immunoassayFolate(vitamin B9) IVD kit chemiluminescent immunoassayIVD General
Phenobarbitaltherapeutic drug monitoring IVD kit chemiluminescent immunoassayPhenobarbitaltherapeutic drug monitoring IVD kit chemiluminescent immunoassayIVD General
Phenobarbitaltherapeutic drug monitoring IVD kit enzyme immunoassay (EIA)Phenobarbitaltherapeutic drug monitoring IVD kit enzyme immunoassay (EIA)IVD General
Carbamazepinetherapeutic drug monitoring IVD kit chemiluminescent immunoassayCarbamazepinetherapeutic drug monitoring IVD kit chemiluminescent immunoassayIVD General
Digitoxintherapeutic drug monitoring IVD kit chemiluminescent immunoassayDigitoxintherapeutic drug monitoring IVD kit chemiluminescent immunoassayIVD General
Estradiol(oestradiol) (E2) IVD kit chemiluminescent immunoassayEstradiol(oestradiol) (E2) IVD kit chemiluminescent immunoassayIVD General
Tissue inhibitor of matrix metalloproteinase-1 (TIMP-1) IVD kit chemiluminescent immunoassayTissue inhibitor of matrix metalloproteinase-1 (TIMP-1) IVD kit chemiluminescent immunoassayIVD General
Cancer antigen 15-3 (CA15-3) IVD kit chemiluminescent immunoassayCancer antigen 15-3 (CA15-3) IVD kit chemiluminescent immunoassayIVD General
Cancerantigen19-9 (CA19-9) IVD kit chemiluminescent immunoassayCancerantigen19-9 (CA19-9) IVD kit chemiluminescent immunoassayIVD General
Troponin I IVD kit chemiluminescent immunoassayTroponin I IVD kit chemiluminescent immunoassayIVD General
Gentamicin therapeutic drug monitoring IVD kit nephelometry/turbidimetryGentamicin therapeutic drug monitoring IVD kit nephelometry/turbidimetryIVD General
Multiple form 25-hydroxy vitamin D IVD kit chemiluminescent immunoassayMultiple form 25-hydroxy vitamin D IVD kit chemiluminescent immunoassayIVD General
Carbon dioxide (CO2) IVD kit spectrophotometryCarbon dioxide (CO2) IVD kit spectrophotometryIVD General
Carbon dioxide (CO2) IVD calibratorCarbon dioxide (CO2) IVD calibratorIVD General
Vitamin B12 IVD kit chemiluminescent immunoassayVitamin B12 IVD kit chemiluminescent immunoassayIVD General
Inorganic phosphate (PO43-) IVD kit spectrophotometryInorganic phosphate (PO43-) IVD kit spectrophotometryIVD General
Treponema pallidum total antibody IVD kit chemiluminescent immunoassayTreponema pallidum total antibody IVD kit chemiluminescent immunoassayIVD General
Multiple apolipoprotein IVD calibratorMultiple apolipoprotein IVD calibratorIVD General
Albumin IVD kit spectrophotometryAlbumin IVD kit spectrophotometryIVD General
Amylase isoenzyme IVD kit enzyme spectrophotometryAmylase isoenzyme IVD kit enzyme spectrophotometryIVD General
Digoxin therapeutic drug monitoring IVD kit nephelometry/turbidimetryDigoxin therapeutic drug monitoring IVD kit nephelometry/turbidimetryIVD General
Wash/cleaning solution IVD automated/semi-automated systemWash/cleaning solution IVD automated/semi-automated systemIVD General
Valproic acid therapeutic drug monitoring IVD kit enzyme immunoassay (EIA)Valproic acid therapeutic drug monitoring IVD kit enzyme immunoassay (EIA)IVD General
Theophylline therapeutic drug monitoring IVD kit enzyme immunoassay (EIA)Theophylline therapeutic drug monitoring IVD kit enzyme immunoassay (EIA)IVD General
Carbamazepine therapeutic drug monitoring IVD kit enzyme immunoassay (EIA)Carbamazepine therapeutic drug monitoring IVD kit enzyme immunoassay (EIA)IVD General
Transferrin IVD kit nephelometry/turbidimetryTransferrin IVD kit nephelometry/turbidimetryIVD General
Myoglobin IVD kit nephelometry/turbidimetryMyoglobin IVD kit nephelometry/turbidimetryIVD General
2-ethylidine-15-dimethyl-33-diphenylpyrrolidine (EDDP) IVD kit enzyme immunoassay (EIA)2-ethylidine-15-dimethyl-33-diphenylpyrrolidine (EDDP) IVD kit enzyme immunoassay (EIA)IVD General
Apolipoprotein A-I (Apo A1) IVD kit nephelometry/turbidimetryApolipoprotein A-I (Apo A1) IVD kit nephelometry/turbidimetryIVD General
Triglyceride IVD kit enzyme spectrophotometryTriglyceride IVD kit enzyme spectrophotometryIVD General
Microalbumin IVD kit nephelometry/turbidimetryMicroalbumin IVD kit nephelometry/turbidimetryIVD General
Apolipoprotein B (Apo B) IVD kit nephelometry/turbidimetryApolipoprotein B (Apo B) IVD kit nephelometry/turbidimetryIVD General
Microalbumin IVD calibratorMicroalbumin IVD calibratorIVD General
Uric acid IVD kit enzyme spectrophotometryUric acid IVD kit enzyme spectrophotometryIVD General
Albumin IVD kit nephelometry/turbidimetryAlbumin IVD kit nephelometry/turbidimetryIVD General
Alpha-1-antitrypsin (protease inhibitor) IVD kit nephelometry/turbidimetryAlpha-1-antitrypsin (protease inhibitor) IVD kit nephelometry/turbidimetryIVD General
Alpha-1-acid glycoprotein (orosomucoid) IVD kit nephelometry/turbidimetryAlpha-1-acid glycoprotein (orosomucoid) IVD kit nephelometry/turbidimetryIVD General
Complement components C3/C3c IVD kit nephelometry/turbidimetryComplement components C3/C3c IVD kit nephelometry/turbidimetryIVD General
Urea IVD kit enzyme spectrophotometryUrea IVD kit enzyme spectrophotometryIVD General
Complement components C4/C4c IVD kit nephelometry/turbidimetryComplement components C4/C4c IVD kit nephelometry/turbidimetryIVD General
Glycated haemoglobin (HbA1c) IVD kit nephelometry/turbidimetryGlycated haemoglobin (HbA1c) IVD kit nephelometry/turbidimetryIVD General
Haptoglobin IVD kit nephelometry/turbidimetryHaptoglobin IVD kit nephelometry/turbidimetryIVD General
Homocysteine IVD calibratorHomocysteine IVD calibratorIVD General
Total immunoglobulin E (IgE total) IVD kit chemiluminescent immunoassayTotal immunoglobulin E (IgE total) IVD kit chemiluminescent immunoassayIVD General
Total immunoglobulin A (IgA total) IVD kit nephelometry/turbidimetryTotal immunoglobulin A (IgA total) IVD kit nephelometry/turbidimetryIVD General
Interleukin-6 (IL-6) IVD kit chemiluminescent immunoassayInterleukin-6 (IL-6) IVD kit chemiluminescent immunoassayIVD General
Interleukin-6 (IL-6) IVD controlInterleukin-6 (IL-6) IVD controlIVD General
Erythropoietin (EPO) IVD kit chemiluminescent immunoassayErythropoietin (EPO) IVD kit chemiluminescent immunoassayIVD General
Total immunoglobulin G (IgG total) IVD kit nephelometry/turbidimetryTotal immunoglobulin G (IgG total) IVD kit nephelometry/turbidimetryIVD General
Total immunoglobulin M (IgM total) IVD kit nephelometry/turbidimetryTotal immunoglobulin M (IgM total) IVD kit nephelometry/turbidimetryIVD General
Total iron binding capacity (TIBC) IVD kit spectrophotometryTotal iron binding capacity (TIBC) IVD kit spectrophotometryIVD General
Beta-2-microglobulin IVD kit nephelometry/turbidimetryBeta-2-microglobulin IVD kit nephelometry/turbidimetryIVD General
Myoglobin IVD kit chemiluminescent immunoassayMyoglobin IVD kit chemiluminescent immunoassayIVD General
Total protein IVD kit enzyme spectrophotometryTotal protein IVD kit enzyme spectrophotometryIVD General
Prealbumin (transthyretin) IVD kit nephelometry/turbidimetryPrealbumin (transthyretin) IVD kit nephelometry/turbidimetryIVD General
Troponin I IVD controlTroponin I IVD controlIVD General
Total protein IVD calibratorTotal protein IVD calibratorIVD General
Total cortisol IVD kit chemiluminescent immunoassayTotal cortisol IVD kit chemiluminescent immunoassayIVD General
Total cortisol IVD reagentTotal cortisol IVD reagentIVD General
C-peptide IVD kit chemiluminescent immunoassayC-peptide IVD kit chemiluminescent immunoassayIVD General
Dehydroepiandrosterone sulfate (DHEAS) IVD kit chemiluminescent immunoassayDehydroepiandrosterone sulfate (DHEAS) IVD kit chemiluminescent immunoassayIVD General
Follicle stimulating hormone (FSH) IVD kit chemiluminescent immunoassayFollicle stimulating hormone (FSH) IVD kit chemiluminescent immunoassayIVD General
Total human chorionic gonadotropin (HCG) IVD kit chemiluminescent immunoassayTotal human chorionic gonadotropin (HCG) IVD kit chemiluminescent immunoassayIVD General
Insulin IVD kit chemiluminescent immunoassayInsulin IVD kit chemiluminescent immunoassayIVD General
Luteinizing hormone (LH) IVD kit chemiluminescent immunoassayLuteinizing hormone (LH) IVD kit chemiluminescent immunoassayIVD General
Parathyroid hormone (PTH) IVD kit chemiluminescent immunoassayParathyroid hormone (PTH) IVD kit chemiluminescent immunoassayIVD General
Progesterone IVD kit chemiluminescent immunoassayProgesterone IVD kit chemiluminescent immunoassayIVD General
Prolactin IVD kit chemiluminescent immunoassayProlactin IVD kit chemiluminescent immunoassayIVD General
Thyroglobulin antibody IVD kit chemiluminescent immunoassayThyroglobulin antibody IVD kit chemiluminescent immunoassayIVD General
Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD kit chemiluminescent immunoassayThyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD kit chemiluminescent immunoassayIVD General
Total triiodothyronine (TT3) IVD kit chemiluminescent immunoassayTotal triiodothyronine (TT3) IVD kit chemiluminescent immunoassayIVD General
Alpha-fetoprotein (AFP) IVD kit chemiluminescent immunoassayAlpha-fetoprotein (AFP) IVD kit chemiluminescent immunoassayIVD General
Thyroid stimulating hormone (TSH) IVD kit chemiluminescent immunoassayThyroid stimulating hormone (TSH) IVD kit chemiluminescent immunoassayIVD General
Free thyroxine (FT4) IVD kit chemiluminescent immunoassayFree thyroxine (FT4) IVD kit chemiluminescent immunoassayIVD General
Free triiodothyronine (FT3) IVD kit chemiluminescent immunoassayFree triiodothyronine (FT3) IVD kit chemiluminescent immunoassayIVD General
Folate (vitamin B9) IVD reagentFolate (vitamin B9) IVD reagentIVD General
Multiple form 25-hydroxy Vitamin D IVD controlMultiple form 25-hydroxy Vitamin D IVD controlIVD General
Cancer antigen 27-29 (CA27-29) IVD kit chemiluminescent immunoassayCancer antigen 27-29 (CA27-29) IVD kit chemiluminescent immunoassayIVD General
Total thyroxine (TT4) IVD kit chemiluminescent immunoassayTotal thyroxine (TT4) IVD kit chemiluminescent immunoassayIVD General
Cancer antigen 27-29 (CA27-29) IVD calibratorCancer antigen 27-29 (CA27-29) IVD calibratorIVD General
Cancer antigen 27-29 (CA27-29) IVD reagentCancer antigen 27-29 (CA27-29) IVD reagentIVD General
Cancer antigen 125 (CA125) IVD kit chemiluminescent immunoassayCancer antigen 125 (CA125) IVD kit chemiluminescent immunoassayIVD General
Carcinoembryonic antigen (CEA) IVD kit chemiluminescent immunoassayCarcinoembryonic antigen (CEA) IVD kit chemiluminescent immunoassayIVD General
Cyclic citrullinated peptide antibody (anti-CCP) IVD controlCyclic citrullinated peptide antibody (anti-CCP) IVD controlIVD General
Thyroglobulin antibody IVD calibratorThyroglobulin antibody IVD calibratorIVD General
Thyroglobulin antibody IVD controlThyroglobulin antibody IVD controlIVD General
Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD calibratorThyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD calibratorIVD General
Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD controlThyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD controlIVD General
Theophylline therapeutic drug monitoring IVD calibratorTheophylline therapeutic drug monitoring IVD calibratorIVD General
Gentamicin therapeutic drug monitoring IVD kit enzyme immunoassay (EIA)Gentamicin therapeutic drug monitoring IVD kit enzyme immunoassay (EIA)IVD General
Gentamicin therapeutic drug monitoring IVD calibratorGentamicin therapeutic drug monitoring IVD calibratorIVD General
Vancomycin therapeutic drug monitoring IVD calibratorVancomycin therapeutic drug monitoring IVD calibratorIVD General
Multiple-therapy therapeutic drug monitoring IVD calibratorMultiple-therapy therapeutic drug monitoring IVD calibratorIVD General
Digoxin therapeutic drug monitoring IVD kit chemiluminescent assayDigoxin therapeutic drug monitoring IVD kit chemiluminescent assayIVD General
Phenobarbital therapeutic drug monitoring IVD calibratorPhenobarbital therapeutic drug monitoring IVD calibratorIVD General
Phenytoin therapeutic drug monitoring IVD kit enzyme immunoassay (EIA)Phenytoin therapeutic drug monitoring IVD kit enzyme immunoassay (EIA)IVD General
Phenytoin therapeutic drug monitoring IVD calibratorPhenytoin therapeutic drug monitoring IVD calibratorIVD General
Valproic acid therapeutic drug monitoring IVD calibratorValproic acid therapeutic drug monitoring IVD calibratorIVD General
Cyclosporin A/cyclosporine therapeutic drug monitoring IVD calibratorCyclosporin A/cyclosporine therapeutic drug monitoring IVD calibratorIVD General
Cyclosporin A/cyclosporine therapeutic drug monitoring IVD reagentCyclosporin A/cyclosporine therapeutic drug monitoring IVD reagentIVD General
Acetaminophen IVD kit enzyme immunoassay (EIA)Acetaminophen IVD kit enzyme immunoassay (EIA)IVD General
Amphetamine/methamphetamine group IVD kit enzyme immunoassay (EIA)Amphetamine/methamphetamine group IVD kit enzyme immunoassay (EIA)IVD General
Amphetamine-specific IVD kit enzyme immunoassay (EIA)Amphetamine-specific IVD kit enzyme immunoassay (EIA)IVD General
Methamphetamine-specific IVD kit enzyme immunoassay (EIA)Methamphetamine-specific IVD kit enzyme immunoassay (EIA)IVD General
Barbiturate IVD kit enzyme immunoassay (EIA)Barbiturate IVD kit enzyme immunoassay (EIA)IVD General
Benzodiazepine group IVD kit enzyme immunoassay (EIA)Benzodiazepine group IVD kit enzyme immunoassay (EIA)IVD General
Cannabinoid/cannabinoid metabolite IVD kit enzyme immunoassay (EIA)Cannabinoid/cannabinoid metabolite IVD kit enzyme immunoassay (EIA)IVD General
Cocaine/cocaine metabolite IVD kit enzyme immunoassay (EIA)Cocaine/cocaine metabolite IVD kit enzyme immunoassay (EIA)IVD General
Ethanol (ETOH) IVD kit enzyme spectrophotometryEthanol (ETOH) IVD kit enzyme spectrophotometryIVD General
Methadone IVD kit enzyme immunoassay (EIA)Methadone IVD kit enzyme immunoassay (EIA)IVD General
Opiate/opiate metabolite IVD kit enzyme immunoassay (EIA)Opiate/opiate metabolite IVD kit enzyme immunoassay (EIA)IVD General
Phencyclidine (PCP) IVD kit enzyme immunoassay (EIA)Phencyclidine (PCP) IVD kit enzyme immunoassay (EIA)IVD General
Phenobarbital IVD kit nephelometry/turbidimetryPhenobarbital IVD kit nephelometry/turbidimetryIVD General
Propoxyphene IVD kit enzyme immunoassay (EIA)Propoxyphene IVD kit enzyme immunoassay (EIA)IVD General
Salicylate IVD kit enzyme spectrophotometrySalicylate IVD kit enzyme spectrophotometryIVD General
Full blood count IVD kit cell countFull blood count IVD kit cell countIVD General
Full blood count IVD reagentFull blood count IVD reagentIVD General
White blood cell count IVD kit cell countWhite blood cell count IVD kit cell countIVD General
Reticulocyte count IVD kit cell countReticulocyte count IVD kit cell countIVD General
Full blood count IVD calibratorFull blood count IVD calibratorIVD General
Full blood count IVD controlFull blood count IVD controlIVD General
Multichannel clinical chemistry analyser IVD laboratoryMultichannel clinical chemistry analyser IVD laboratoryIVD General
C-erbB2/Her2/neu oncoprotein IVD calibratorC-erbB2/Her2/neu oncoprotein IVD calibratorIVD General
C-erbB2/Her2/neu oncoprotein IVD controlC-erbB2/Her2/neu oncoprotein IVD controlIVD General
Specimen processing instrument IVDSpecimen processing instrument IVDIVD General
Optical laboratory instrument performance standard calibrator/control IVD single-useOptical laboratory instrument performance standard calibrator/control IVD single-useIVD General
Sex hormone binding globulin (SHBG) IVD kit chemiluminescent immunoassaySex hormone binding globulin (SHBG) IVD kit chemiluminescent immunoassayIVD General
Buffered sample diluent IVD manualBuffered sample diluent IVD manualIVD General
Human chorionic gonadotropin beta-subunit (beta-HCG) IVD kit chemiluminescent immunoassayHuman chorionic gonadotropin beta-subunit (beta-HCG) IVD kit chemiluminescent immunoassayIVD Annex II List B
Pregnancy-associated plasma protein A (PAPP-A) IVD kit chemiluminescent immunoassayPregnancy-associated plasma protein A (PAPP-A) IVD kit chemiluminescent immunoassayIVD Annex II List B
Procalcitonin (PCT) IVD kit chemiluminescent immunoassayProcalcitonin (PCT) IVD kit chemiluminescent immunoassayIVD General
Buffered wash solution IVD automated/semi-automated systemBuffered wash solution IVD automated/semi-automated systemIVD General
Chlamydia trachomatis nucleic acid IVD kit nucleic acid technique (NAT)Chlamydia trachomatis nucleic acid IVD kit nucleic acid technique (NAT)IVD Annex II List B
Laboratory pH electrodeLaboratory pH electrodeIVD General
Ferritin IVD kit nephelometry/turbidimetryFerritin IVD kit nephelometry/turbidimetryIVD General
Assay container IVD single-useAssay container IVD single-useIVD General
Multiple clinical chemistry enzyme IVD reagentMultiple clinical chemistry enzyme IVD reagentIVD General
Total testosterone IVD kit chemiluminescent immunoassayTotal testosterone IVD kit chemiluminescent immunoassayIVD General
General specimen container IVD no additive/mediumGeneral specimen container IVD no additive/mediumIVD General
Glycated haemoglobin (HbA1c) IVD reagentGlycated haemoglobin (HbA1c) IVD reagentIVD General
Zika virus immunoglobulin M (IgM) antibody IVD kit chemiluminescent immunoassayZika virus immunoglobulin M (IgM) antibody IVD kit chemiluminescent immunoassayIVD General
Differentiation solution IVDDifferentiation solution IVDIVD General
High density lipoprotein (HDL) cholesterol IVD calibratorHigh density lipoprotein (HDL) cholesterol IVD calibratorIVD General
Instrument/analyser test tube rack cover IVDInstrument/analyser test tube rack cover IVDIVD General
Assay container IVD reusableAssay container IVD reusableIVD General
Printer label IVDPrinter label IVDIVD General
SARS-CoV-2 antigen IVD controlSARS-CoV-2 antigen IVD controlIVD General
SARS-CoV-2 antigen IVD kit chemiluminescent immunoassaySARS-CoV-2 antigen IVD kit chemiluminescent immunoassayIVD General
SARS-CoV-2 antigen IVD calibratorSARS-CoV-2 antigen IVD calibratorIVD General
Low density lipoprotein (LDL) cholesterol IVD calibratorLow density lipoprotein (LDL) cholesterol IVD calibratorIVD General
Zika virus immunoglobulin M (IgM) antibody IVD controlZika virus immunoglobulin M (IgM) antibody IVD controlIVD General
Androstenedione IVD kit chemiluminescent immunoassayAndrostenedione IVD kit chemiluminescent immunoassayIVD General
Medical networking interface unit IVDMedical networking interface unit IVDIVD General
Glycated haemoglobin (HbA1c) IVD controlGlycated haemoglobin (HbA1c) IVD controlIVD General
Glycated haemoglobin (HbA1c) IVD kit nephelometry/turbidimetryGlycated haemoglobin (HbA1c) IVD kit nephelometry/turbidimetryIVD General
Full blood count IVD controlFull blood count IVD controlIVD General
Instrument/analyser specimen/reagent container carrier IVDInstrument/analyser specimen/reagent container carrier IVDIVD General
Faecal occult blood IVD kit rapid colorimetric clinicalFaecal occult blood IVD kit rapid colorimetric clinicalIVD General
Multiplex analyser IVD point-of-careMultiplex analyser IVD point-of-careIVD General
Viral inactivation buffer IVDViral inactivation buffer IVDIVD General
Carcinoembryonic antigen (CEA) IVD calibratorCarcinoembryonic antigen (CEA) IVD calibratorIVD General
Beta-2-microglobulin IVD calibratorBeta-2-microglobulin IVD calibratorIVD General
Hepatitis B virus core total antibody IVD controlHepatitis B virus core total antibody IVD controlIVD General
Glycated haemoglobin (HbA1c) IVD controlGlycated haemoglobin (HbA1c) IVD controlIVD General
Hyaluronic acid (HA) IVD controlHyaluronic acid (HA) IVD controlIVD General
Hyaluronic acid (HA) IVD calibratorHyaluronic acid (HA) IVD calibratorIVD General
Hyaluronic acid (HA) IVD kit binding assayHyaluronic acid (HA) IVD kit binding assayIVD General
Procollagen type III C-terminal propeptide IVD kit enzyme immunoassay (EIA)Procollagen type III C-terminal propeptide IVD kit enzyme immunoassay (EIA)IVD General
Procollagen type III C-terminal propeptide IVD calibratorProcollagen type III C-terminal propeptide IVD calibratorIVD General
Procollagen type III C-terminal propeptide IVD controlProcollagen type III C-terminal propeptide IVD controlIVD General
Allergen-specific immunoglobulin E (IgE) antibody IVD kit enzyme immunoassay (EIA)Allergen-specific immunoglobulin E (IgE) antibody IVD kit enzyme immunoassay (EIA)IVD General
Multiple blood gas analyte IVD kit ion-selective electrode (ISE)Multiple blood gas analyte IVD kit ion-selective electrode (ISE)IVD General
Faecal occult blood IVD kit rapid colorimetric clinicalFaecal occult blood IVD kit rapid colorimetric clinicalIVD General
Iron IVD kit enzyme spectrophotometryIron IVD kit enzyme spectrophotometryIVD General
Rheumatoid factor IVD kit agglutinationRheumatoid factor IVD kit agglutinationIVD General
Non-blood cell primer/calibrator/control material IVD reagentNon-blood cell primer/calibrator/control material IVD reagentIVD General
Matrix metalloproteinase-9 (MMP-9) IVD calibratorMatrix metalloproteinase-9 (MMP-9) IVD calibratorIVD General
Matrix metalloproteinase-9 (MMP-9) IVD controlMatrix metalloproteinase-9 (MMP-9) IVD controlIVD General
Microscope slide maker/stainer IVD semi-automatedMicroscope slide maker/stainer IVD semi-automatedIVD General
Total triiodothyronine (TT3) IVD reagentTotal triiodothyronine (TT3) IVD reagentIVD General
Chemiluminescent immunoassay signal generation kit IVDChemiluminescent immunoassay signal generation kit IVDIVD General
Multiple urine analyte IVD kit rapid colorimetric clinicalMultiple urine analyte IVD kit rapid colorimetric clinicalIVD Devices for Self-Testing
Cytomegalovirus (CMV) immunoglobulin M (IgM) antibody IVD controlCytomegalovirus (CMV) immunoglobulin M (IgM) antibody IVD controlIVD Annex II List B
Cytomegalovirus (CMV) immunoglobulin M (IgM) antibody IVD kit chemiluminescent immunoassayCytomegalovirus (CMV) immunoglobulin M (IgM) antibody IVD kit chemiluminescent immunoassayIVD Annex II List B
Assay container liner IVDAssay container liner IVDIVD General
Cystatin C IVD kit nephelometry/turbidimetryCystatin C IVD kit nephelometry/turbidimetryIVD General
Cystatin C IVD calibratorCystatin C IVD calibratorIVD General
Multichannel clinical chemistry analyser IVD point-of-care line-poweredMultichannel clinical chemistry analyser IVD point-of-care line-poweredIVD General
Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD kit nephelometry/turbidimetryBeta-haemolytic Group A Streptococcus streptolysin O antibody IVD kit nephelometry/turbidimetryIVD General
Iron IVD kit spectrophotometryIron IVD kit spectrophotometryIVD General
C-reactive protein (CRP) IVD kit nephelometry/turbidimetryC-reactive protein (CRP) IVD kit nephelometry/turbidimetryIVD General
C-reactive protein (CRP) IVD calibratorC-reactive protein (CRP) IVD calibratorIVD General
Lactate IVD kit enzyme spectrophotometryLactate IVD kit enzyme spectrophotometryIVD General
Creatinine IVD kit enzyme spectrophotometryCreatinine IVD kit enzyme spectrophotometryIVD General
Biological stain IVDBiological stain IVDIVD General
Phosphate buffer/Sorenson buffer solution IVDPhosphate buffer/Sorenson buffer solution IVDIVD General
Multiple clinical chemistry protein IVD calibratorMultiple clinical chemistry protein IVD calibratorIVD General
Anti-Mullerian hormone (AMH) IVD kit chemiluminescent immunoassayAnti-Mullerian hormone (AMH) IVD kit chemiluminescent immunoassayIVD General
Anti-Mullerian hormone (AMH) IVD controlAnti-Mullerian hormone (AMH) IVD controlIVD General
Haptoglobin IVD kit nephelometry/turbidimetryHaptoglobin IVD kit nephelometry/turbidimetryIVD General
Pseudocholinesterase IVD kit enzyme spectrophotometryPseudocholinesterase IVD kit enzyme spectrophotometryIVD General
Squamous cell carcinoma antigen IVD kit chemiluminescent immunoassaySquamous cell carcinoma antigen IVD kit chemiluminescent immunoassayIVD General
Squamous cell carcinoma antigen IVD calibratorSquamous cell carcinoma antigen IVD calibratorIVD General
Squamous cell carcinoma antigen IVD controlSquamous cell carcinoma antigen IVD controlIVD General
SARS-CoV-2 total antibody IVD kit chemiluminescent immunoassaySARS-CoV-2 total antibody IVD kit chemiluminescent immunoassayIVD General
SARS-CoV-2 total antibody IVD controlSARS-CoV-2 total antibody IVD controlIVD General
Multiple liver fibrosis marker IVD kit chemiluminescent immunoassayMultiple liver fibrosis marker IVD kit chemiluminescent immunoassayIVD General
Buffered sample diluent IVD automated/semi-automated systemBuffered sample diluent IVD automated/semi-automated systemIVD General
SARS-CoV-2 immunoglobulin G (IgG) antibody IVD controlSARS-CoV-2 immunoglobulin G (IgG) antibody IVD controlIVD General
SARS-CoV-2 immunoglobulin G (IgG) antibody IVD kit chemiluminescent immunoassaySARS-CoV-2 immunoglobulin G (IgG) antibody IVD kit chemiluminescent immunoassayIVD General
Total bilirubin IVD kit spectrophotometryTotal bilirubin IVD kit spectrophotometryIVD General
Myoglobin IVD calibratorMyoglobin IVD calibratorIVD General
Multiple therapeutic drugs/drugs of abuse IVD controlMultiple therapeutic drugs/drugs of abuse IVD controlIVD General
2-ethylidine-15-dimethyl-33-diphenylpyrrolidine (EDDP) IVD calibrator2-ethylidine-15-dimethyl-33-diphenylpyrrolidine (EDDP) IVD calibratorIVD General
Chemiluminescent immunoassay analyser IVDChemiluminescent immunoassay analyser IVDIVD General
General laboratory assay trayGeneral laboratory assay trayIVD General
Lithium therapeutic drug monitoring IVD kit atomic spectroscopyLithium therapeutic drug monitoring IVD kit atomic spectroscopyIVD General
Hepatitis B virus e-antigen total antibody IVD kit chemiluminescent immunoassayHepatitis B virus e-antigen total antibody IVD kit chemiluminescent immunoassayIVD Annex II List A
Hepatitis B virus e-antigen total antibody IVD controlHepatitis B virus e-antigen total antibody IVD controlIVD Annex II List A
Thermal cycler nucleic acid amplification analyser IVD laboratoryThermal cycler nucleic acid amplification analyser IVD laboratoryIVD General