Manufacturer's Devices - Ortho-Clinical Diagnostics

Address:




Felindre Meadows Pencoed



Bridgend

CF35 5PZ

Wales United Kingdom


Authorised Representative/ UK Responsible Person
Name: Not Available

Address:







Code/Term Type
SARS-CoV-2 antigen IVD kit chemiluminescent immunoassaySARS-CoV-2 antigen IVD kit chemiluminescent immunoassayIVD General
SARS-CoV-2 antigen IVD controlSARS-CoV-2 antigen IVD controlIVD General
Cancer antigen 15-3 (CA15-3) IVD kit chemiluminescent immunoassayCancer antigen 15-3 (CA15-3) IVD kit chemiluminescent immunoassayIVD General
Cancer antigen 125 (CA125) IVD kit chemiluminescent immunoassayCancer antigen 125 (CA125) IVD kit chemiluminescent immunoassayIVD General
Cancerantigen19-9 (CA19-9) IVD kit chemiluminescent immunoassayCancerantigen19-9 (CA19-9) IVD kit chemiluminescent immunoassayIVD General
Hepatitis A virus total antibody IVD controlHepatitis A virus total antibody 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
Collagen type I cross-linked C-telopeptide IVD kit chemiluminescent immunoassayCollagen type I cross-linked C-telopeptide IVD kit chemiluminescent immunoassayIVD General
Hepatitis A virus immunoglobulin M (IgM) antibody IVD controlHepatitis A virus immunoglobulin M (IgM) antibody IVD controlIVD General
Free thyroxine (FT4) IVD controlFree thyroxine (FT4) IVD controlIVD General
Hepatitis A virus total antibody IVD kit chemiluminescent immunoassayHepatitis A virus total antibody IVD kit chemiluminescent immunoassayIVD General
Hepatitis A virus immunoglobulin M (IgM) antibody IVD kit chemiluminescent immunoassayHepatitis A virus immunoglobulin M (IgM) antibody IVD kit chemiluminescent immunoassayIVD General
Troponin I IVD calibratorTroponin I IVD calibratorIVD General
Troponin I IVD controlTroponin I IVD controlIVD General
C-peptide IVD kit chemiluminescent immunoassayC-peptide IVD kit chemiluminescent immunoassayIVD General
Insulin IVD kit chemiluminescent immunoassayInsulin IVD kit chemiluminescent immunoassayIVD General
Total cortisol IVD kit chemiluminescent immunoassayTotal cortisol 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
Thyroid stimulating hormone (TSH) IVD kit chemiluminescent immunoassayThyroid stimulating hormone (TSH) 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
Luteinizing hormone (LH) IVD kit chemiluminescent immunoassayLuteinizing hormone (LH) IVD kit chemiluminescent immunoassayIVD General
Carcinoembryonic antigen (CEA) IVD kit chemiluminescent immunoassayCarcinoembryonic antigen (CEA) IVD kit chemiluminescent immunoassayIVD General
Free triiodothyronine (FT3) IVD kit chemiluminescent immunoassayFree triiodothyronine (FT3) IVD kit chemiluminescent immunoassayIVD General
Free thyroxine (FT4) IVD kit chemiluminescent immunoassayFree thyroxine (FT4) IVD kit chemiluminescent immunoassayIVD General
Multiple acute kidney injury (AKI) marker IVD controlMultiple acute kidney injury (AKI) marker IVD controlIVD General
Alpha-fetoprotein (AFP) IVD kit chemiluminescent immunoassayAlpha-fetoprotein (AFP) IVD kit chemiluminescent immunoassayIVD General
Total triiodothyronine (TT3) IVD kit chemiluminescent immunoassayTotal triiodothyronine (TT3) IVD kit chemiluminescent immunoassayIVD General
Total thyroxine (TT4) IVD kit chemiluminescent immunoassayTotal thyroxine (TT4) IVD kit chemiluminescent immunoassayIVD General
Multiple acute kidney injury (AKI) marker IVD calibratorMultiple acute kidney injury (AKI) marker IVD calibratorIVD General
Estradiol(oestradiol) (E2) IVD kit chemiluminescent immunoassayEstradiol(oestradiol) (E2) IVD kit chemiluminescent immunoassayIVD General
Troponin I IVD kit chemiluminescent immunoassayTroponin I IVD kit chemiluminescent immunoassayIVD General
Vitamin B12 IVD kit chemiluminescent immunoassayVitamin B12 IVD kit chemiluminescent immunoassayIVD General
Creatinekinasemyocardialisoenzyme (CKMB) IVD kit chemiluminescent immunoassayCreatinekinasemyocardialisoenzyme (CKMB) IVD kit chemiluminescent immunoassayIVD General
FerritinIVD kit chemiluminescent immunoassayFerritinIVD kit chemiluminescent immunoassayIVD General
Folate(vitamin B9) IVD kit chemiluminescent immunoassayFolate(vitamin B9) IVD kit chemiluminescent immunoassayIVD General
Total testosterone IVD kit chemiluminescent immunoassayTotal testosterone IVD kit chemiluminescent immunoassayIVD General
Multiple thyroid marker IVD controlMultiple thyroid marker IVD controlIVD General
Multiple acute kidney injury (AKI) marker IVD kit chemiluminescent immunoassayMultiple acute kidney injury (AKI) marker IVD kit chemiluminescent immunoassayIVD General
Trypanosoma cruzi immunoglobulin G (IgG) antibody IVD kit chemiluminescent immunoassayTrypanosoma cruzi immunoglobulin G (IgG) antibody IVD kit chemiluminescent immunoassayIVD General
Multiple anaemia-related analyte IVD controlMultiple anaemia-related analyte IVD controlIVD General
Anti-C^w red blood cell grouping IVD antibodyAnti-C^w red blood cell grouping IVD antibodyIVD General
Anti-A1 red blood cell grouping IVD lectinAnti-A1 red blood cell grouping IVD lectinIVD General
Anti-Le^a red blood cell grouping IVD antibodyAnti-Le^a red blood cell grouping IVD antibodyIVD General
Anti-Le^b red blood cell grouping IVD antibodyAnti-Le^b red blood cell grouping IVD antibodyIVD General
Anti-N red blood cell grouping IVD antibodyAnti-N red blood cell grouping IVD antibodyIVD General
Anti-M red blood cell grouping IVD antibodyAnti-M red blood cell grouping IVD antibodyIVD General
Anti-k (KEL002) red blood cell grouping IVD antibodyAnti-k (KEL002) red blood cell grouping IVD antibodyIVD General
Blood group/antibody screening analyser IVD semi-automatedBlood group/antibody screening analyser IVD semi-automatedIVD General
Anti-S [MNS003] red blood cell grouping IVD antibodyAnti-S [MNS003] red blood cell grouping IVD antibodyIVD General
Anti-S [MNS004] red blood cell grouping IVD antibodyAnti-S [MNS004] red blood cell grouping IVD antibodyIVD 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
C-peptide IVD calibratorC-peptide IVD calibratorIVD General
Chemiluminescent immunoassay signal generation kit IVDChemiluminescent immunoassay signal generation kit IVDIVD General
Protease immunohaematology reagent IVDProtease immunohaematology reagent IVDIVD 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
SARS-CoV-2 immunoglobulin G (IgG) antibody IVD kit chemiluminescent immunoassaySARS-CoV-2 immunoglobulin G (IgG) antibody IVD kit chemiluminescent immunoassayIVD General
SARS-CoV-2 immunoglobulin G (IgG) antibody IVD controlSARS-CoV-2 immunoglobulin G (IgG) antibody IVD controlIVD General
Interleukin-6 (IL-6) IVD controlInterleukin-6 (IL-6) IVD controlIVD General
Interleukin-7 (IL-7) IVD kit enzyme immunoassay (EIA)Interleukin-7 (IL-7) IVD kit enzyme immunoassay (EIA)IVD General
Multiple form 25-hydroxy vitamin D IVD kit chemiluminescent immunoassayMultiple form 25-hydroxy vitamin D IVD kit chemiluminescent immunoassayIVD General
Myoglobin IVD kit chemiluminescent immunoassayMyoglobin IVD kit chemiluminescent immunoassayIVD General
Treponema pallidum total antibody IVD kit chemiluminescent immunoassayTreponema pallidum total antibody IVD kit chemiluminescent immunoassayIVD General
Thyroid uptake (T-uptake) IVD kit chemiluminescent immunoassayThyroid uptake (T-uptake) IVD kit chemiluminescent immunoassayIVD General
Multiple immunohaematology test IVD controlMultiple immunohaematology test IVD controlIVD General
Anti-B red blood cell grouping IVD antibodyAnti-B red blood cell grouping IVD antibodyIVD General
Anti-A red blood cell grouping IVD antibodyAnti-A red blood cell grouping IVD antibodyIVD General
Monospecific immunoglobulin G antihuman globulin (IgG AHG) IVD antibodyMonospecific immunoglobulin G antihuman globulin (IgG AHG) IVD antibodyIVD Annex II List A
Multiple monospecific antihuman globulin/anti-complement cell coat typing IVD kit agglutinationMultiple monospecific antihuman globulin/anti-complement cell coat typing IVD kit agglutinationIVD Annex II List A
Column agglutination IVDColumn agglutination IVDIVD Annex II List B
Monospecific anti-complement component C3b/C3d (anti-C3b/anti-C3d) IVD antibodyMonospecific anti-complement component C3b/C3d (anti-C3b/anti-C3d) IVD antibodyIVD Annex II List B
Anti-Jk^a red blood cell grouping IVD antibodyAnti-Jk^a red blood cell grouping IVD antibodyIVD Annex II List B
Anti-Jk^b red blood cell grouping IVD antibodyAnti-Jk^b red blood cell grouping IVD antibodyIVD Annex II List B
Anti-Fy^a red blood cell grouping IVD antibodyAnti-Fy^a red blood cell grouping IVD antibodyIVD Annex II List B
Anti-Fy^b red blood cell grouping IVD antibodyAnti-Fy^b red blood cell grouping IVD antibodyIVD Annex II List B
Antibody screening reagent red blood cell IVD kit agglutinationAntibody screening reagent red blood cell IVD kit agglutinationIVD Annex II List B
Antibody identification panel reagent red blood cell IVD kit agglutinationAntibody identification panel reagent red blood cell IVD kit agglutinationIVD Annex II List B
Immunoglobulin-sensitized reagent red blood cell IVD controlImmunoglobulin-sensitized reagent red blood cell IVD controlIVD Annex II List B
Group A2 Rh (D) negative reagent red blood cell IVD antigenGroup A2 Rh (D) negative reagent red blood cell IVD antigenIVD Annex II List B
ABO/Rh multiple blood grouping IVD kit agglutinationABO/Rh multiple blood grouping IVD kit agglutinationIVD Annex II List B
Rhesus (Rh) phenotype (CcDEe)/Kell phenotype multiple blood grouping IVD kit agglutinationRhesus (Rh) phenotype (CcDEe)/Kell phenotype multiple blood grouping IVD kit agglutinationIVD Annex II List B
Rhesus (Rh) phenotype (CcDEe) multiple blood grouping IVD kit agglutinationRhesus (Rh) phenotype (CcDEe) multiple blood grouping IVD kit agglutinationIVD Annex II List B
ABO/Rh(D)/IgG multiple blood grouping IVD kit agglutinationABO/Rh(D)/IgG multiple blood grouping IVD kit agglutinationIVD Annex II List B
ABO/Rh(D)/Kell multiple blood grouping IVD kit agglutinationABO/Rh(D)/Kell multiple blood grouping IVD kit agglutinationIVD Annex II List A
Reverse ABO grouping reagent red blood cell (A1/A2/B/AB/O) IVD kit agglutinationReverse ABO grouping reagent red blood cell (A1/A2/B/AB/O) IVD kit agglutinationIVD Annex II List A
Anti-C [RH002] red blood cell grouping IVD antibodyAnti-C [RH002] red blood cell grouping IVD antibodyIVD Annex II List A
Anti-E [RH003] red blood cell grouping IVD antibodyAnti-E [RH003] red blood cell grouping IVD antibodyIVD Annex II List A
Anti-C [RH004] red blood cell grouping IVD antibodyAnti-C [RH004] red blood cell grouping IVD antibodyIVD Annex II List A
Anti-E [RH005] red blood cell grouping IVD antibodyAnti-E [RH005] red blood cell grouping IVD antibodyIVD Annex II List A
Anti-Rh(D) red blood cell grouping IVD antibodyAnti-Rh(D) red blood cell grouping IVD antibodyIVD Annex II List A
Antisera matrix (non-reactive) IVD controlAntisera matrix (non-reactive) IVD controlIVD Annex II List A
Anti-K (KEL001) red blood cell grouping IVD antibodyAnti-K (KEL001) red blood cell grouping IVD antibodyIVD Annex II List A
Hepatitis C virus antibody/antigen IVD kit enzyme immunoassay (EIA)Hepatitis C virus antibody/antigen IVD kit enzyme immunoassay (EIA)IVD Annex II List A
Anti-AB red blood cell grouping IVD antibodyAnti-AB red blood cell grouping IVD antibodyIVD Annex II List A
Hepatitis B virus e-antigen IVD controlHepatitis B virus e-antigen IVD controlIVD 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 core total antibody IVD controlHepatitis B virus core total 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 IVD kit chemiluminescent immunoassayHepatitis B virus e-antigen 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
Total prostate specific antigen (tPSA) IVD kit chemiluminescent immunoassayTotal prostate specific antigen (tPSA) IVD kit chemiluminescent immunoassayIVD 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 B virus surface antigen IVD controlHepatitis B virus surface antigen 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 kit chemiluminescent immunoassayHepatitis B virus core total antibody IVD kit chemiluminescent immunoassayIVD 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 C virus total antibody IVD kit chemiluminescent assayHepatitis C virus total antibody IVD kit chemiluminescent assayIVD Annex II List A
Hepatitis C virus total antibody IVD controlHepatitis C virus total antibody IVD controlIVD 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
HIV1 antibody IVD controlHIV1 antibody IVD controlIVD Annex II List A
HIV1 antigen IVD controlHIV1 antigen IVD controlIVD 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
Human T-cell lymphotrophic virus 1 & 2 (HTLV1 & HTLV2) antibody IVD controlHuman T-cell lymphotrophic virus 1 & 2 (HTLV1 & HTLV2) antibody IVD controlIVD Annex II List B
Rubellavirus immunoglobulin G (IgG) antibody IVD kit chemiluminescent immunoassayRubellavirus immunoglobulin G (IgG) antibody IVD kit chemiluminescent immunoassayIVD Annex II List A
Rubella virus immunoglobulin M (IgM) antibody IVD kit chemiluminescent immunoassayRubella virus immunoglobulin M (IgM) antibody IVD kit chemiluminescent immunoassayIVD Annex II List A
Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD kit chemiluminescent immunoassayCytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD kit chemiluminescent immunoassayIVD Annex II List A
Cytomegalovirus (CMV) immunoglobulin M (IgM) antibody IVD kit chemiluminescent immunoassayCytomegalovirus (CMV) immunoglobulin M (IgM) antibody IVD kit chemiluminescent immunoassayIVD Annex II List A
Toxoplasma gondii immunoglobulin G (IgG) antibody IVD kit chemiluminescent immunoassayToxoplasma gondii immunoglobulin G (IgG) antibody IVD kit chemiluminescent immunoassayIVD Annex II List A
Hepatitis B virus surface immunoglobulin M (IgM) antibody IVD controlHepatitis B virus surface immunoglobulin M (IgM) antibody IVD controlIVD Annex II List A
Free (unbound) prostate specific antigen (fPSA) IVD kit chemiluminescent immunoassayFree (unbound) prostate specific antigen (fPSA) IVD kit chemiluminescent immunoassayIVD 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 A
Immunoassay reagent vehicle tray IVD reusableImmunoassay reagent vehicle tray IVD reusableIVD Annex II List A
Test tube/reservoir cap IVDTest tube/reservoir cap IVDIVD Annex II List A
Buffered sample diluent IVDBuffered sample diluent IVDIVD Annex II List A
Bovine serum albumin (BSA) immunohaematology reagent IVDBovine serum albumin (BSA) immunohaematology reagent IVDIVD Annex II List A
Low ionic-strength salt solution (LISS) immunohaematology reagent IVDLow ionic-strength salt solution (LISS) immunohaematology reagent IVDIVD Annex II List A
Clinical specimen extraction buffer IVDClinical specimen extraction buffer IVDIVD Annex II List B
Blood group/antibody screening analyser IVDBlood group/antibody screening analyser IVDIVD Annex II List B
Immunohaematology/blood bank analyser IVDImmunohaematology/blood bank analyser IVDIVD Annex II List B
Agglutination assay digital imaging reader/analyser IVDAgglutination assay digital imaging reader/analyser IVDIVD Annex II List B
Assay container IVD single-useAssay container IVD single-useIVD Annex II List B
Procalcitonin (PCT) IVD controlProcalcitonin (PCT) IVD controlIVD Annex II List A
Procalcitonin (PCT) IVD kit chemiluminescent immunoassayProcalcitonin (PCT) IVD kit chemiluminescent immunoassayIVD Annex II List B
Procalcitonin (PCT) IVD kit chemiluminescent immunoassayProcalcitonin (PCT) IVD kit chemiluminescent immunoassayIVD Annex II List B
Procalcitonin (PCT) IVD kit chemiluminescent immunoassayProcalcitonin (PCT) IVD kit chemiluminescent immunoassayClass A
Procalcitonin (PCT) IVD kit chemiluminescent immunoassayProcalcitonin (PCT) IVD kit chemiluminescent immunoassayClass A
Procalcitonin (PCT) IVD kit chemiluminescent immunoassayProcalcitonin (PCT) IVD kit chemiluminescent immunoassayClass A
Procalcitonin (PCT) IVD kit chemiluminescent immunoassayProcalcitonin (PCT) IVD kit chemiluminescent immunoassayClass A
Procalcitonin (PCT) IVD kit chemiluminescent immunoassayProcalcitonin (PCT) IVD kit chemiluminescent immunoassayClass A
Procalcitonin (PCT) IVD kit chemiluminescent immunoassayProcalcitonin (PCT) IVD kit chemiluminescent immunoassayClass A
Procalcitonin (PCT) IVD kit chemiluminescent immunoassayProcalcitonin (PCT) IVD kit chemiluminescent immunoassayClass A
Procalcitonin (PCT) IVD kit chemiluminescent immunoassayProcalcitonin (PCT) IVD kit chemiluminescent immunoassayClass A
Procalcitonin (PCT) IVD kit chemiluminescent immunoassayProcalcitonin (PCT) IVD kit chemiluminescent immunoassayClass A
Procalcitonin (PCT) IVD kit chemiluminescent immunoassayProcalcitonin (PCT) IVD kit chemiluminescent immunoassayIVD General
Procalcitonin (PCT) IVD kit chemiluminescent immunoassayProcalcitonin (PCT) IVD kit chemiluminescent immunoassayIVD General
Procalcitonin (PCT) IVD kit chemiluminescent immunoassayProcalcitonin (PCT) IVD kit chemiluminescent immunoassayIVD General
Procalcitonin (PCT) IVD kit chemiluminescent immunoassayProcalcitonin (PCT) IVD kit chemiluminescent immunoassayIVD General