Manufacturer's Devices - Abbott GmbH

Address:




Max-Planck-Ring 2



Wiesbaden

65205

Germany


Authorised Representative/ UK Responsible Person
Name: Abbott Laboratories Limited
Address:

Abbott House Vanwall Business Park Vanwall Road



Maidenhead

Berkshire SL64XE

England United Kingdom



Code/Term Type
Treponema pallidum total antibody IVD controlTreponema pallidum total antibody IVD controlIVD General
Treponema pallidum total antibody IVD kit chemiluminescent immunoassayTreponema pallidum total antibody IVD kit chemiluminescent immunoassayIVD General
Treponema pallidum immunoglobulin G (IgG)/IgM antibody IVD kit chemiluminescent immunoassayTreponema pallidum immunoglobulin G (IgG)/IgM antibody IVD kit chemiluminescent immunoassayIVD General
Trypanosoma cruzi total antibody IVD calibratorTrypanosoma cruzi total antibody IVD calibratorIVD General
Trypanosoma cruzi total antibody IVD controlTrypanosoma cruzi total antibody IVD controlIVD General
Des-gamma-carboxyprothrombin (DCP) IVD calibratorDes-gamma-carboxyprothrombin (DCP) IVD calibratorIVD General
Des-gamma-carboxyprothrombin (DCP) IVD controlDes-gamma-carboxyprothrombin (DCP) IVD controlIVD General
Des-gamma-carboxyprothrombin (DCP) IVD kit chemiluminescent immunoassayDes-gamma-carboxyprothrombin (DCP) IVD kit chemiluminescent immunoassayIVD General
Hepatitis A virus immunoglobulin M (IgM) antibody IVD calibratorHepatitis A virus immunoglobulin M (IgM) antibody IVD calibratorIVD General
Hepatitis A virus immunoglobulin M (IgM) antibody IVD controlHepatitis A virus immunoglobulin M (IgM) antibody IVD controlIVD General
Hepatitis A virus immunoglobulin M (IgM) antibody IVD kit chemiluminescent immunoassayHepatitis A virus immunoglobulin M (IgM) antibody IVD kit chemiluminescent immunoassayIVD General
Insulin IVD calibratorInsulin IVD calibratorIVD General
Insulin IVD controlInsulin IVD controlIVD General
Insulin IVD kit chemiluminescent immunoassayInsulin IVD kit chemiluminescent immunoassayIVD General
Total testosterone IVD calibratorTotal testosterone IVD calibratorIVD General
Total testosterone IVD controlTotal testosterone IVD controlIVD General
Total testosterone IVD kit chemiluminescent immunoassayTotal testosterone 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
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
Hepatitis A virus immunoglobulin G (IgG) antibody IVD calibratorHepatitis A virus immunoglobulin G (IgG) antibody IVD calibratorIVD General
Hepatitis A virus immunoglobulin G (IgG) antibody IVD controlHepatitis A virus immunoglobulin G (IgG) antibody IVD controlIVD General
Hepatitis A virus immunoglobulin G (IgG) antibody IVD kit chemiluminescent immunoassayHepatitis A virus immunoglobulin G (IgG) antibody IVD kit chemiluminescent immunoassayIVD General
Parathyroid hormone (PTH) IVD calibratorParathyroid hormone (PTH) IVD calibratorIVD General
Parathyroid hormone (PTH) IVD controlParathyroid hormone (PTH) IVD controlIVD General
Parathyroid hormone (PTH) IVD kit chemiluminescent immunoassayParathyroid hormone (PTH) IVD kit chemiluminescent immunoassayIVD General
Chemiluminescent immunoassay analyser IVDChemiluminescent immunoassay analyser IVDIVD General
Cancer antigen 19-9 (CA19-9) IVD calibratorCancer antigen 19-9 (CA19-9) IVD calibratorIVD General
Cancer antigen 19-9 (CA19-9) IVD controlCancer antigen 19-9 (CA19-9) IVD controlIVD General
Cancerantigen19-9 (CA19-9) IVD kit chemiluminescent immunoassayCancerantigen19-9 (CA19-9) IVD kit chemiluminescent immunoassayIVD General
Cancer antigen 125 (CA125) IVD calibratorCancer antigen 125 (CA125) IVD calibratorIVD General
Cancer antigen 125 (CA125) IVD controlCancer antigen 125 (CA125) IVD controlIVD General
Cancer antigen 125 (CA125) IVD kit chemiluminescent immunoassayCancer antigen 125 (CA125) IVD kit chemiluminescent immunoassayIVD General
Human epididymis protein 4 (HE4) IVD calibratorHuman epididymis protein 4 (HE4) IVD calibratorIVD General
Human epididymis protein 4 (HE4) IVD controlHuman epididymis protein 4 (HE4) IVD controlIVD General
Human epididymis protein 4 (HE4) IVD kit chemiluminescent immunoassayHuman epididymis protein 4 (HE4) IVD kit chemiluminescent immunoassayIVD General
Cancer antigen 15-3 (CA15-3) IVD calibratorCancer antigen 15-3 (CA15-3) IVD calibratorIVD General
Cancer antigen 15-3 (CA15-3) IVD controlCancer antigen 15-3 (CA15-3) IVD controlIVD General
Cancer antigen 15-3 (CA15-3) IVD kit chemiluminescent immunoassayCancer antigen 15-3 (CA15-3) IVD kit chemiluminescent immunoassayIVD General
Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD calibratorEpstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD calibratorIVD General
Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD controlEpstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD controlIVD General
Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD kit chemiluminescent immunoassayEpstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD kit chemiluminescent immunoassayIVD General
Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD calibratorEpstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD calibratorIVD General
Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD controlEpstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD controlIVD General
Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD kit chemiluminescent immunoassayEpstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD kit chemiluminescent immunoassayIVD General
Pepsinogen I IVD calibratorPepsinogen I IVD calibratorIVD General
Pepsinogen I IVD controlPepsinogen I IVD controlIVD General
Pepsinogen I IVD kit chemiluminescent immunoassayPepsinogen I IVD kit chemiluminescent immunoassayIVD General
Pepsinogen II IVD calibratorPepsinogen II IVD calibratorIVD General
Pepsinogen II IVD kit chemiluminescent immunoassayPepsinogen II IVD kit chemiluminescent immunoassayIVD General
Vitamin B12 IVD calibratorVitamin B12 IVD calibratorIVD General
Vitamin B12 IVD controlVitamin B12 IVD controlIVD General
Vitamin B12 IVD kit chemiluminescent immunoassayVitamin B12 IVD kit chemiluminescent immunoassayIVD General
Cyclic citrullinated peptide antibody (anti-CCP) IVD calibratorCyclic citrullinated peptide antibody (anti-CCP) IVD calibratorIVD General
Cyclic citrullinated peptide antibody (anti-CCP) IVD controlCyclic citrullinated peptide antibody (anti-CCP) IVD controlIVD General
Cyclic citrullinated peptide antibody (anti-CCP) IVD kit chemiluminescent immunoassayCyclic citrullinated peptide antibody (anti-CCP) IVD kit chemiluminescent immunoassayIVD General
Homocysteine IVD calibratorHomocysteine IVD calibratorIVD General
Homocysteine IVD controlHomocysteine IVD controlIVD General
HomocysteineIVD kit chemiluminescent immunoassayHomocysteineIVD kit chemiluminescent immunoassayIVD General
Progastrin-releasing peptide (ProGRP) IVD calibratorProgastrin-releasing peptide (ProGRP) IVD calibratorIVD General
Progastrin-releasing peptide (ProGRP) IVD controlProgastrin-releasing peptide (ProGRP) IVD controlIVD General
Progastrin-releasing peptide (ProGRP) IVD kit chemiluminescent immunoassayProgastrin-releasing peptide (ProGRP) 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
Squamous cell carcinoma antigen IVD kit chemiluminescent immunoassaySquamous cell carcinoma antigen IVD kit chemiluminescent immunoassayIVD General
C-peptide IVD calibratorC-peptide IVD calibratorIVD General
C-peptide IVD controlC-peptide IVD controlIVD General
C-peptide IVD kit chemiluminescent immunoassayC-peptide IVD kit chemiluminescent immunoassayIVD General
Dehydroepiandrosterone sulfate (DHEAS) IVD calibratorDehydroepiandrosterone sulfate (DHEAS) IVD calibratorIVD General
Dehydroepiandrosterone sulfate (DHEAS) IVD controlDehydroepiandrosterone sulfate (DHEAS) IVD controlIVD General
Dehydroepiandrosterone sulfate (DHEAS) IVD kit chemiluminescent immunoassayDehydroepiandrosterone sulfate (DHEAS) IVD kit chemiluminescent immunoassayIVD General
Sex hormone binding globulin (SHBG) IVD calibratorSex hormone binding globulin (SHBG) IVD calibratorIVD General
Sex hormone binding globulin (SHBG) IVD controlSex hormone binding globulin (SHBG) IVD controlIVD General
Sex hormone binding globulin (SHBG) IVD kit chemiluminescent immunoassaySex hormone binding globulin (SHBG) IVD kit chemiluminescent immunoassayIVD General
Cytokeratin IVD calibratorCytokeratin IVD calibratorIVD General
Cytokeratin IVD controlCytokeratin IVD controlIVD General
Cytokeratin IVD kit chemiluminescent immunoassayCytokeratin IVD kit chemiluminescent immunoassayIVD General
Methotrexate therapeutic drug monitoring IVD calibratorMethotrexate therapeutic drug monitoring IVD calibratorIVD General
Methotrexate therapeutic drug monitoring IVD controlMethotrexate therapeutic drug monitoring IVD controlIVD General
Methotrexate therapeutic drug monitoring IVD kit chemiluminescent immunoassayMethotrexate therapeutic drug monitoring IVD kit chemiluminescent immunoassayIVD General
Galectin-3 IVD calibratorGalectin-3 IVD calibratorIVD General
Galectin-3 IVD controlGalectin-3 IVD controlIVD General
Galectin-3 IVD kit chemiluminescent immunoassayGalectin-3 IVD kit chemiluminescent immunoassayIVD General
Neuron-specific enolase (NSE) IVD calibratorNeuron-specific enolase (NSE) IVD calibratorIVD General
Neuron-specific enolase (NSE) IVD controlNeuron-specific enolase (NSE) IVD controlIVD General
Neuron-specific enolase (NSE) IVD kit chemiluminescent immunoassayNeuron-specific enolase (NSE) IVD kit chemiluminescent immunoassayIVD General
Thyroglobulin IVD kit chemiluminescent immunoassayThyroglobulin IVD kit chemiluminescent immunoassayIVD General
Thyroglobulin IVD calibratorThyroglobulin IVD calibratorIVD General
Thyroglobulin IVD controlThyroglobulin IVD controlIVD General
Haematological cell analyser IVDHaematological cell analyser IVDIVD General
Buffered sample diluent IVD automated/semi-automated systemBuffered sample diluent IVD automated/semi-automated systemIVD General
Full blood count IVD controlFull blood count IVD controlIVD General
Full blood count IVD calibratorFull blood count IVD calibratorIVD General
Microscope slide maker/stainer IVDMicroscope slide maker/stainer IVDIVD General
General specimen microscopy slide IVD single-useGeneral specimen microscopy slide IVD single-useIVD General
Reagent grade alcohol solution IVDReagent grade alcohol solution IVDIVD General
Biological stain IVDBiological stain IVDIVD General
Multiple clinical chemistry analyser IVD laboratoryMultiple clinical chemistry analyser IVD laboratoryIVD General
Plasma protein IVD calibratorPlasma protein IVD calibratorIVD General
Prealbumin (transthyretin) IVD calibratorPrealbumin (transthyretin) IVD calibratorIVD General
Iron IVD calibratorIron IVD calibratorIVD General
Total bilirubin IVD kit spectrophotometryTotal bilirubin IVD kit spectrophotometryIVD General
Total protein IVD reagentTotal protein IVD reagentIVD General
Buffered sample diluent IVD manualBuffered sample diluent IVD manualIVD General
Glucose IVD kit enzyme spectrophotometryGlucose IVD kit enzyme spectrophotometryIVD General
Calcium (Ca2+) IVD kit spectrophotometryCalcium (Ca2+) IVD kit spectrophotometryIVD General
Total amylase IVD reagentTotal amylase IVD reagentIVD General
Total microprotein IVD kit nephelometry/turbidimetryTotal microprotein IVD kit nephelometry/turbidimetryIVD General
Carbon dioxide (CO2) IVD kit spectrophotometryCarbon dioxide (CO2) IVD kit spectrophotometryIVD General
Gamma-glutamyltransferase (GGT) IVD reagentGamma-glutamyltransferase (GGT) IVD reagentIVD General
Total lactate dehydrogenase (LDH) IVD kit enzyme spectrophotometryTotal lactate dehydrogenase (LDH) IVD kit enzyme spectrophotometryIVD General
High density lipoprotein (HDL) cholesterol IVD reagentHigh density lipoprotein (HDL) cholesterol IVD reagentIVD General
Total cholesterol lipid IVD reagentTotal cholesterol lipid IVD reagentIVD General
Triglyceride IVD reagentTriglyceride IVD reagentIVD General
Conjugated (direct) bilirubin IVD reagentConjugated (direct) bilirubin IVD reagentIVD General
Alanine aminotransferase (ALT) IVD reagentAlanine aminotransferase (ALT) IVD reagentIVD General
Creatinine IVD kit spectrophotometryCreatinine IVD kit spectrophotometryIVD General
Albumin IVD reagentAlbumin IVD reagentIVD General
Microalbumin IVD calibratorMicroalbumin IVD calibratorIVD General
Microalbumin IVD controlMicroalbumin IVD controlIVD General
Microalbumin IVD kit nephelometry/turbidimetryMicroalbumin IVD kit nephelometry/turbidimetryIVD General
Urea IVD reagentUrea IVD reagentIVD General
Total aspartate aminotransferase (AST) IVD kit enzyme spectrophotometryTotal aspartate aminotransferase (AST) IVD kit enzyme spectrophotometryIVD General
Magnesium (Mg2+) IVD kit spectrophotometryMagnesium (Mg2+) IVD kit spectrophotometryIVD General
Total alkaline phosphatase (ALP) IVD reagentTotal alkaline phosphatase (ALP) IVD reagentIVD General
Lactate IVD kit reduction/oxidationLactate IVD kit reduction/oxidationIVD General
Total aspartate aminotransferase (AST) IVD reagentTotal aspartate aminotransferase (AST) IVD reagentIVD General
Transferrin IVD kit nephelometry/turbidimetryTransferrin IVD kit nephelometry/turbidimetryIVD General
Inorganic phosphate (PO43-) IVD reagentInorganic phosphate (PO43-) IVD reagentIVD General
Total creatine kinase (CK) IVD reagentTotal creatine kinase (CK) IVD reagentIVD General
Glycated haemoglobin (HbA1c) IVD calibratorGlycated haemoglobin (HbA1c) IVD calibratorIVD 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
Uric acid IVD kit spectrophotometryUric acid IVD kit spectrophotometryIVD General
Multiple-type clinical chemistry analyte profile IVD calibratorMultiple-type clinical chemistry analyte profile IVD calibratorIVD General
Total bilirubin IVD calibratorTotal bilirubin IVD calibratorIVD General
Multiple electrolyte IVD calibratorMultiple electrolyte IVD calibratorIVD General
Total microprotein IVD calibratorTotal microprotein IVD calibratorIVD General
Carbon dioxide (CO2) IVD calibratorCarbon dioxide (CO2) IVD calibratorIVD General
Ion selective electrode (ISE) reference solution IVD reagentIon selective electrode (ISE) reference solution IVD reagentIVD General
Wash/cleaning solution IVD automated/semi-automated systemWash/cleaning solution IVD automated/semi-automated systemIVD General
Multiple lipid analyte IVD calibratorMultiple lipid analyte IVD calibratorIVD General
Apolipoprotein A-I (Apo A1) IVD reagentApolipoprotein A-I (Apo A1) IVD reagentIVD General
Apolipoprotein B (Apo B) IVD reagentApolipoprotein B (Apo B) IVD reagentIVD General
Complement components C3/C3c IVD reagentComplement components C3/C3c IVD reagentIVD General
Complement components C4/C4c IVD reagentComplement components C4/C4c IVD reagentIVD General
Haptoglobin IVD reagentHaptoglobin IVD reagentIVD General
Total immunoglobulin A (IgA total) IVD kit nephelometry/turbidimetryTotal immunoglobulin A (IgA total) IVD kit nephelometry/turbidimetryIVD General
Immunoglobulin G subclass (IgG subclass) IVD kit nephelometry/turbidimetryImmunoglobulin G subclass (IgG subclass) IVD kit nephelometry/turbidimetryIVD General
Total immunoglobulin M (IgM total) IVD kit nephelometry/turbidimetryTotal immunoglobulin M (IgM total) IVD kit nephelometry/turbidimetryIVD General
Prealbumin (transthyretin) IVD kit nephelometry/turbidimetryPrealbumin (transthyretin) IVD kit nephelometry/turbidimetryIVD General
Theophylline therapeutic drug monitoring IVD calibratorTheophylline therapeutic drug monitoring IVD calibratorIVD General
Theophyllinetherapeutic drug monitoring IVD kit chemiluminescent immunoassayTheophyllinetherapeutic drug monitoring IVD kit chemiluminescent immunoassayIVD General
Vancomycin therapeutic drug monitoring IVD calibratorVancomycin therapeutic drug monitoring IVD calibratorIVD General
Vancomycintherapeutic drug monitoring IVD kit chemiluminescent immunoassayVancomycintherapeutic drug monitoring IVD kit chemiluminescent immunoassayIVD General
Gentamicin therapeutic drug monitoring IVD calibratorGentamicin therapeutic drug monitoring IVD calibratorIVD General
Gentamicintherapeutic drug monitoring IVD kit chemiluminescent immunoassayGentamicintherapeutic drug monitoring IVD kit chemiluminescent immunoassayIVD General
Carbamazepine therapeutic drug monitoring IVD calibratorCarbamazepine therapeutic drug monitoring IVD calibratorIVD General
Carbamazepinetherapeutic drug monitoring IVD kit chemiluminescent immunoassayCarbamazepinetherapeutic drug monitoring IVD kit chemiluminescent immunoassayIVD General
Procalcitonin (PCT) IVD calibratorProcalcitonin (PCT) IVD calibratorIVD General
Procalcitonin (PCT) IVD controlProcalcitonin (PCT) IVD controlIVD General
Procalcitonin (PCT) IVD kit chemiluminescent immunoassayProcalcitonin (PCT) IVD kit chemiluminescent immunoassayIVD General
Chemiluminescent immunoassay oxidizing reagent IVDChemiluminescent immunoassay oxidizing reagent IVDIVD General
Multiple blood-borne virus antigen/antibody IVD controlMultiple blood-borne virus antigen/antibody IVD controlIVD Annex II List A
Toxoplasma gondii immunoglobulin M (IgM) antibody IVD kit chemiluminescent immunoassayToxoplasma gondii immunoglobulin M (IgM) antibody IVD kit chemiluminescent immunoassayIVD Annex II List B
Hepatitis B virus surface antigen IVD kit chemiluminescent immunoassayHepatitis B virus surface antigen IVD kit chemiluminescent immunoassayIVD Annex II List A
Treponema pallidum total antibody IVD calibratorTreponema pallidum total antibody IVD calibratorIVD General
Trypanosoma cruzi total antibody IVD kit chemiluminescent immunoassayTrypanosoma cruzi total antibody IVD kit chemiluminescent immunoassayIVD General
Pepsinogen II IVD controlPepsinogen II IVD controlIVD General
Buffered wash solution IVD automated/semi-automated systemBuffered wash solution IVD automated/semi-automated systemIVD General
MDR-TB/XDR-TB nucleic acid IVD kit nucleic acid technique (NAT)MDR-TB/XDR-TB nucleic acid IVD kit nucleic acid technique (NAT)IVD General
MDR-TB/XDR-TB nucleic acid IVD controlMDR-TB/XDR-TB nucleic acid IVD controlIVD General
Laboratory instrument/analyser application software IVDLaboratory instrument/analyser application software IVDIVD General
Mycobacterium tuberculosis nucleic acid IVD kit nucleic acid technique (NAT)Mycobacterium tuberculosis nucleic acid IVD kit nucleic acid technique (NAT)IVD General
Mycobacterium tuberculosis nucleic acid IVD controlMycobacterium tuberculosis nucleic acid IVD controlIVD General
Human papillomavirus (HPV) high risk strain nucleic acid IVD kit nucleic acid technique (NAT)Human papillomavirus (HPV) high risk strain nucleic acid IVD kit nucleic acid technique (NAT)IVD General
Human papillomavirus (HPV) high-risk strain nucleic acid IVD controlHuman papillomavirus (HPV) high-risk strain nucleic acid IVD controlIVD General
Deionization water purification systemDeionization water purification systemClass I
Microscope slide labelling cartridge IVDMicroscope slide labelling cartridge IVDIVD General
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 calibratorToxoplasma gondii immunoglobulin M (IgM) antibody IVD calibratorIVD 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
Toxoplasma gondii immunoglobulin G (IgG) antibody avidity index IVD controlToxoplasma gondii immunoglobulin G (IgG) antibody avidity index IVD controlIVD Annex II List B
Toxoplasma gondii immunoglobulin G (IgG) antibody avidity index IVD kit chemiluminescent immunoassayToxoplasma gondii immunoglobulin G (IgG) antibody avidity index IVD kit chemiluminescent immunoassayIVD Annex II List B
Toxoplasma gondii immunoglobulin G (IgG) antibody IVD calibratorToxoplasma gondii immunoglobulin G (IgG) antibody 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
HIV1/HIV2 antigen/antibody IVD kit chemiluminescent immunoassayHIV1/HIV2 antigen/antibody IVD kit chemiluminescent immunoassayIVD Annex II List A
HIV1/HIV2 antigen/antibody IVD calibratorHIV1/HIV2 antigen/antibody IVD calibratorIVD Annex II List A
HIV1/HIV2 antigen/antibody IVD controlHIV1/HIV2 antigen/antibody IVD controlIVD Annex II List A
Hepatitis C virus total antibody IVD calibratorHepatitis C virus total antibody IVD calibratorIVD Annex II List A
Hepatitis C virus total antibody IVD controlHepatitis C virus total antibody IVD controlIVD 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 core total antibody IVD calibratorHepatitis B virus core total antibody IVD calibratorIVD Annex II List A
Hepatitis B virus e-antigen IVD controlHepatitis B virus e-antigen IVD control Conformity Assessment Certificate ExpiredIVD Annex II List A
Hepatitis B virus core immunoglobulin M (IgM) antibody IVD calibratorHepatitis B virus core immunoglobulin M (IgM) antibody IVD calibratorIVD 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 immunoglobulin M (IgM) antibody IVD kit chemiluminescent immunoassayHepatitis B virus core immunoglobulin M (IgM) antibody IVD kit chemiluminescent immunoassayIVD Annex II List A
Hepatitis B virus e-antigen total antibody IVD calibratorHepatitis B virus e-antigen total antibody IVD calibratorIVD 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
Hepatitis C virus core antigen IVD controlHepatitis C virus core antigen IVD controlIVD Annex II List A
Hepatitis C virus core antigen IVD kit chemiluminescent immunoassayHepatitis C virus core antigen IVD kit chemiluminescent immunoassayIVD 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
Human T-cell lymphotrophic virus 1 & 2 (HTLV1 & HTLV2) antibody IVD kit chemiluminescent immunoassayHuman T-cell lymphotrophic virus 1 & 2 (HTLV1 & HTLV2) antibody IVD kit chemiluminescent immunoassayIVD Annex II List A
Hepatitis C virus core antigen IVD calibratorHepatitis C virus core antigen IVD calibrator Conformity Assessment Certificate ExpiredIVD Annex II List A
Human T-cell lymphotrophic virus 1 & 2 (HTLV1 & HTLV2) antibody IVD calibratorHuman T-cell lymphotrophic virus 1 & 2 (HTLV1 & HTLV2) antibody IVD calibrator Conformity Assessment Certificate ExpiredIVD Annex II List A
Human T-cell lymphotrophic virus 1 & 2 (HTLV1 & HTLV2) antibody IVD controlHuman T-cell lymphotrophic virus 1 & 2 (HTLV1 & HTLV2) antibody IVD control Conformity Assessment Certificate ExpiredIVD 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 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 IVD calibratorHepatitis B virus e-antigen IVD calibratorIVD Annex II List A
Hepatitis B virus e-antigen IVD kit chemiluminescent immunoassayHepatitis B virus e-antigen IVD kit chemiluminescent immunoassay Conformity Assessment Certificate ExpiredIVD Annex II List A
Blood smearing cassette IVDBlood smearing cassette IVDClass A
Differentiation solution IVDDifferentiation solution IVDClass A