Manufacturer's Devices - Ortho-Clinical Diagnostics Inc.

Address:




100 Indigo Creek Drive



Rochester

New York 14626

United States


Authorised Representative/ UK Responsible Person
Name: Ortho-Clinical Diagnostics
Address:

Felindre Meadows Pencoed



Bridgend

CF35 5PZ

Wales United Kingdom




Code/Term Type
Alpha-1-antitrypsin (protease inhibitor) IVD kit nephelometry/turbidimetryAlpha-1-antitrypsin (protease inhibitor) IVD kit nephelometry/turbidimetryIVD General
Acetaminophen IVD reagentAcetaminophen IVD reagentIVD General
Alanine aminotransferase (ALT) IVD reagentAlanine aminotransferase (ALT) IVD reagentIVD General
Ammonia IVD reagentAmmonia IVD reagentIVD General
Amphetamine/methamphetamine group IVD kit enzyme immunoassay (EIA)Amphetamine/methamphetamine group IVD kit enzyme immunoassay (EIA)IVD General
Apolipoprotein A-I (Apo A1) IVD calibratorApolipoprotein A-I (Apo A1) IVD calibratorIVD General
Apolipoprotein A-I (Apo A1) IVD controlApolipoprotein A-I (Apo A1) IVD controlIVD General
Albumin IVD reagentAlbumin IVD reagentIVD General
Apolipoprotein B (Apo B) IVD calibratorApolipoprotein B (Apo B) IVD calibratorIVD General
Apolipoprotein A-I (Apo A1) IVD kit nephelometry/turbidimetryApolipoprotein A-I (Apo A1) IVD kit nephelometry/turbidimetryIVD 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
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
Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD calibratorBeta-haemolytic Group A Streptococcus streptolysin O antibody IVD calibratorIVD General
Apolipoprotein B (Apo B) IVD kit nephelometry/turbidimetryApolipoprotein B (Apo B) IVD kit nephelometry/turbidimetryIVD General
Assay container IVD single-useAssay container IVD single-useIVD General
Caffeine IVD kit enzyme immunoassay (EIA)Caffeine IVD kit enzyme immunoassay (EIA)IVD General
Calcium (Ca2+) IVD reagentCalcium (Ca2+) IVD reagentIVD General
Cannabinoid/cannabinoid metabolite IVD calibratorCannabinoid/cannabinoid metabolite IVD calibratorIVD General
Carbamazepine therapeutic drug monitoring IVD reagentCarbamazepine therapeutic drug monitoring IVD reagentIVD General
Carbon dioxide (CO2) IVD reagentCarbon dioxide (CO2) IVD reagentIVD General
C-reactive protein (CRP) IVD reagentC-reactive protein (CRP) IVD reagentIVD General
Cannabinoid/cannabinoid metabolite IVD kit enzyme immunoassay (EIA)Cannabinoid/cannabinoid metabolite IVD kit enzyme immunoassay (EIA)IVD General
Chloride (Cl-) IVD reagentChloride (Cl-) IVD reagentIVD General
Cholinesterase dibucaine number (percentage inhibition) IVD reagentCholinesterase dibucaine number (percentage inhibition) IVD reagentIVD General
Cocaine/cocaine metabolite IVD kit enzyme immunoassay (EIA)Cocaine/cocaine metabolite IVD kit enzyme immunoassay (EIA)IVD General
Creatine kinase myocardial isoenzyme (CKMB) IVD reagentCreatine kinase myocardial isoenzyme (CKMB) IVD reagentIVD General
Creatinine IVD reagentCreatinine IVD reagentIVD General
Digoxin therapeutic drug monitoring IVD reagentDigoxin therapeutic drug monitoring IVD reagentIVD General
Complement components C3/C3c IVD kit nephelometry/turbidimetryComplement components C3/C3c IVD kit nephelometry/turbidimetryIVD General
Complement components C4/C4c IVD kit nephelometry/turbidimetryComplement components C4/C4c IVD kit nephelometry/turbidimetryIVD General
Ethanol (ETOH) IVD calibratorEthanol (ETOH) IVD calibratorIVD General
Ethanol (ETOH) IVD reagentEthanol (ETOH) IVD reagentIVD General
Gamma-glutamyltransferase (GGT) IVD reagentGamma-glutamyltransferase (GGT) IVD reagentIVD General
Gentamicin therapeutic drug monitoring IVD kit enzyme immunoassay (EIA)Gentamicin therapeutic drug monitoring IVD kit enzyme immunoassay (EIA)IVD General
Glucose IVD reagentGlucose IVD reagentIVD General
Glycated haemoglobin (HbA1c) IVD controlGlycated haemoglobin (HbA1c) IVD controlIVD General
Haptoglobin IVD kit nephelometry/turbidimetryHaptoglobin IVD kit nephelometry/turbidimetryIVD General
Gentamicin therapeutic drug monitoring IVD calibratorGentamicin therapeutic drug monitoring IVD calibratorIVD General
Glycated haemoglobin (HbA1c) IVD kit nephelometry/turbidimetryGlycated haemoglobin (HbA1c) IVD kit nephelometry/turbidimetryIVD General
High density lipoprotein (HDL) cholesterol IVD reagentHigh density lipoprotein (HDL) cholesterol IVD reagentIVD General
Homocysteine IVD kit enzyme spectrophotometryHomocysteine IVD kit enzyme spectrophotometryIVD General
Inorganic phosphate (PO43-) IVD reagentInorganic phosphate (PO43-) IVD reagentIVD General
High density lipoprotein (HDL) cholesterol IVD calibratorHigh density lipoprotein (HDL) cholesterol IVD calibratorIVD General
Homocysteine IVD calibratorHomocysteine IVD calibratorIVD General
Iron IVD reagentIron IVD reagentIVD General
Lactate IVD reagentLactate IVD reagentIVD General
Lipase IVD reagentLipase IVD reagentIVD General
Low density lipoprotein (LDL) cholesterol IVD calibratorLow density lipoprotein (LDL) cholesterol IVD calibratorIVD General
Magnesium (Mg2+) IVD reagentMagnesium (Mg2+) IVD reagentIVD General
Methadone IVD kit enzyme immunoassay (EIA)Methadone IVD kit enzyme immunoassay (EIA)IVD General
Low density lipoprotein (LDL) cholesterol IVD kit enzyme spectrophotometryLow density lipoprotein (LDL) cholesterol IVD kit enzyme spectrophotometryIVD General
Microalbumin IVD calibratorMicroalbumin IVD calibratorIVD General
Lithium therapeutic drug monitoring IVD reagentLithium therapeutic drug monitoring IVD reagentIVD General
Multiple clinical chemistry enzyme IVD calibratorMultiple clinical chemistry enzyme IVD calibratorIVD General
Microalbumin IVD kit nephelometry/turbidimetryMicroalbumin IVD kit nephelometry/turbidimetryIVD General
Microalbumin IVD controlMicroalbumin IVD controlIVD General
Multiple cardiac marker IVD controlMultiple cardiac marker IVD controlIVD General
Multiple-therapy therapeutic drug monitoring IVD controlMultiple-therapy therapeutic drug monitoring IVD controlIVD General
Multiple clinical chemistry protein IVD controlMultiple clinical chemistry protein IVD controlIVD General
Multiple-type clinical chemistry analyte profile IVD calibratorMultiple-type clinical chemistry analyte profile IVD calibratorIVD General
Multiple therapeutic drugs/drugs of abuse IVD calibratorMultiple therapeutic drugs/drugs of abuse IVD calibratorIVD General
Multiple-therapy therapeutic drug monitoring IVD calibratorMultiple-therapy therapeutic drug monitoring IVD calibratorIVD 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
Phenytoin therapeutic drug monitoring IVD reagentPhenytoin therapeutic drug monitoring IVD reagentIVD General
Multiple-type clinical chemistry analyte profile IVD controlMultiple-type clinical chemistry analyte profile IVD controlIVD General
Multiple-type clinical chemistry analyte profile IVD reagentMultiple-type clinical chemistry analyte profile IVD reagentIVD General
Potassium (K+) IVD reagentPotassium (K+) IVD reagentIVD General
Rheumatoid factor IVD kit agglutinationRheumatoid factor IVD kit agglutinationIVD General
Prealbumin (transthyretin) IVD calibratorPrealbumin (transthyretin) IVD calibratorIVD General
Prealbumin (transthyretin) IVD controlPrealbumin (transthyretin) IVD controlIVD General
Rheumatoid factor IVD calibratorRheumatoid factor IVD calibratorIVD General
Prealbumin (transthyretin) IVD kit nephelometry/turbidimetryPrealbumin (transthyretin) IVD kit nephelometry/turbidimetryIVD General
Total alkaline phosphatase (ALP) IVD reagentTotal alkaline phosphatase (ALP) IVD reagentIVD General
Total amylase IVD reagentTotal amylase IVD reagentIVD General
Total aspartate aminotransferase (AST) IVD reagentTotal aspartate aminotransferase (AST) IVD reagentIVD General
Total bilirubin IVD reagentTotal bilirubin IVD reagentIVD General
Sodium (Na+) IVD reagentSodium (Na+) IVD reagentIVD General
Theophylline therapeutic drug monitoring IVD reagentTheophylline therapeutic drug monitoring IVD reagentIVD General
Salicylate IVD reagentSalicylate IVD reagentIVD General
Tobramycin therapeutic drug monitoring IVD calibratorTobramycin therapeutic drug monitoring IVD calibratorIVD General
Tobramycintherapeutic drug monitoring IVD kit enzyme immunoassay (EIA)Tobramycintherapeutic drug monitoring IVD kit enzyme immunoassay (EIA)IVD General
Total cholesterol lipid IVD reagentTotal cholesterol lipid IVD reagentIVD General
Total immunoglobulin A (IgA total) IVD kit nephelometry/turbidimetryTotal immunoglobulin A (IgA total) IVD kit nephelometry/turbidimetryIVD General
Total immunoglobulin G (IgG total) IVD kit nephelometry/turbidimetryTotal immunoglobulin G (IgG total) IVD kit nephelometry/turbidimetryIVD General
Total creatine kinase (CK) IVD reagentTotal creatine kinase (CK) IVD reagentIVD 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
Total lactate dehydrogenase (LDH) IVD reagentTotal lactate dehydrogenase (LDH) IVD reagentIVD General
Total iron binding capacity (TIBC) IVD calibratorTotal iron binding capacity (TIBC) IVD calibratorIVD General
Total iron binding capacity (TIBC) IVD controlTotal iron binding capacity (TIBC) IVD controlIVD General
Total protein IVD calibratorTotal protein IVD calibratorIVD General
Urea IVD reagentUrea IVD reagentIVD General
Transferrin IVD kit nephelometry/turbidimetryTransferrin IVD kit nephelometry/turbidimetryIVD General
Triglyceride IVD reagentTriglyceride IVD reagentIVD General
Total protein IVD reagentTotal protein IVD reagentIVD General
Transferrin IVD calibratorTransferrin IVD calibratorIVD General
Total protein IVD controlTotal protein IVD controlIVD General
Uric acid IVD reagentUric acid IVD reagentIVD General
Valproic acid therapeutic drug monitoring IVD calibratorValproic acid therapeutic drug monitoring IVD calibratorIVD General
Vancomycintherapeutic drug monitoring IVD kit enzyme immunoassay (EIA)Vancomycintherapeutic drug monitoring IVD kit enzyme immunoassay (EIA)IVD General
Vancomycin therapeutic drug monitoring IVD calibratorVancomycin therapeutic drug monitoring IVD calibratorIVD General
Valproic acid therapeutic drug monitoring IVD kit enzyme immunoassay (EIA)Valproic acid therapeutic drug monitoring IVD kit enzyme immunoassay (EIA)IVD 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
Phenobarbital therapeutic drug monitoring IVD reagentPhenobarbital therapeutic drug monitoring IVD reagentIVD General
Glycated haemoglobin (HbA1c) IVD calibratorGlycated haemoglobin (HbA1c) IVD calibratorIVD General
Glycated haemoglobin (HbA1c) IVD kit enzyme spectrophotometryGlycated haemoglobin (HbA1c) IVD kit enzyme 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
Laboratory analyser cuvette IVD single-useLaboratory analyser cuvette IVD single-useClass A
Dry clinical chemistry analyser IVD automatedDry clinical chemistry analyser IVD automatedIVD General
Buffered sample diluent IVD manualBuffered sample diluent IVD manualIVD General
General specimen container IVD no additive/mediumGeneral specimen container IVD no additive/mediumClass A
Bovine serum albumin (BSA) immunohaematology reagent IVDBovine serum albumin (BSA) immunohaematology reagent IVDIVD General
Buffered sample diluent IVDBuffered sample diluent IVDClass A
Chemiluminescent immunoassay analyser IVDChemiluminescent immunoassay analyser IVDClass A
Multiple clinical chemistry analyser IVD laboratoryMultiple clinical chemistry analyser IVD laboratoryClass A
Buffered wash solution IVDBuffered wash solution IVDClass A
Laboratory analyser operation system software IVDLaboratory analyser operation system software IVDClass A
Laboratory analyser operation system software IVDLaboratory analyser operation system software IVDIVD General
Laboratory analyser operation system software IVDLaboratory analyser operation system software IVDIVD General
Laboratory analyser operation system software IVDLaboratory analyser operation system software IVDIVD General