Manufacturer's Devices - National Institute for Biological Standards and Control (NIBSC)

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Blanche Lane South Mimms



Potters Bar

Hertfordshire EN6 3QG

United Kingdom


Authorised Representative/ UK Responsible Person
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Code/Term Type
HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD controlHIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD controlIVD Annex II List A
Hepatitis C virus total antibody IVD controlHepatitis C virus total antibody IVD controlIVD Annex II List A
Adenovirus nucleic acid IVD reagentAdenovirus nucleic acid IVD reagentIVD General
Epstein-Barr virus (EBV) nucleic acid IVD reagentEpstein-Barr virus (EBV) nucleic acid IVD reagentIVD General
Hepatitis B virus antigen/antibody marker IVD reagentHepatitis B virus antigen/antibody marker IVD reagentIVD Annex II List A
HSV - NA ReagentsHSV - NA ReagentsIVD General
Other Monogenetic Disorders TestsOther Monogenetic Disorders TestsIVD General
Measles - NA ReagentsMeasles - NA ReagentsIVD General
Varicella Zoster Virus IgGVaricella Zoster Virus IgGIVD General
Other Virology - NA ReagentsOther Virology - NA ReagentsIVD General
HIV1 antibody IVD controlHIV1 antibody IVD controlIVD Annex II List A
HIV2 antibody IVD controlHIV2 antibody IVD controlIVD Annex II List A
Hepatitis C virus total antibody IVD controlHepatitis C virus 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
HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD controlHIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD controlIVD 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 B virus core immunoglobulin M (IgM) antibody IVD controlHepatitis B virus core immunoglobulin M (IgM) antibody IVD controlIVD Annex II List A
Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD controlCytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD controlIVD Annex II List B
Rubella virus immunoglobulin G (IgG) antibody IVD controlRubella virus immunoglobulin G (IgG) antibody IVD controlIVD Annex II List B
Rubella virus immunoglobulin M (IgM) antibody IVD controlRubella virus immunoglobulin M (IgM) antibody IVD controlIVD Annex II List B
Toxoplasma gondii immunoglobulin G (IgG) antibody IVD controlToxoplasma gondii immunoglobulin G (IgG) antibody IVD controlIVD Annex II List B
Borrelia burgdorferi immunoglobulin G (IgG) antibody IVD controlBorrelia burgdorferi immunoglobulin G (IgG) antibody IVD controlIVD General
Antisera matrix (non-reactive) IVD controlAntisera matrix (non-reactive) IVD controlIVD General
Ferritin IVD controlFerritin IVD controlIVD General
HLA class I & II antibody screening IVD controlHLA class I & II antibody screening IVD controlIVD General
Hepatitis B virus core total antibody IVD controlHepatitis B virus core total antibody 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
Anti-Rh(D) standard reference solution IVDAnti-Rh(D) standard reference solution IVDIVD Annex II List B
Anti-C [RH004] standard reference solution IVDAnti-C [RH004] standard reference solution IVDIVD Annex II List B
HIV2 antibody IVD controlHIV2 antibody IVD controlIVD Annex II List A
Human T-cell lymphotrophic virus 1 (HTLV1) antibody IVD controlHuman T-cell lymphotrophic virus 1 (HTLV1) antibody IVD controlIVD Annex II List A
Hepatitis C virus total antibody IVD controlHepatitis C virus 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
Multiple respiratory virus nucleic acid IVD controlMultiple respiratory virus nucleic acid IVD controlIVD General
SARS-CoV-2 nucleic acid IVD controlSARS-CoV-2 nucleic acid IVD controlIVD General
HIV1 antigen IVD controlHIV1 antigen IVD controlIVD Annex II List A
HLA class I & II antibody screening IVD reagentHLA class I & II antibody screening IVD reagentIVD General
Other Virology Controls - Inf.ImmOther Virology Controls - Inf.ImmIVD General
Bacterial toxin IVD reagentBacterial toxin IVD reagentIVD General
Multiple respiratory virus nucleic acid IVD reagentMultiple respiratory virus nucleic acid IVD reagentIVD General
HIV1 nucleic acid IVD reagentHIV1 nucleic acid IVD reagentIVD Annex II List A
HLA class I & II antibody screening IVD reagentHLA class I & II antibody screening IVD reagentIVD General
HLA-DR antigen nucleic acid tissue typing IVD controlHLA-DR antigen nucleic acid tissue typing IVD controlIVD Annex II List B
Human metapneumovirus (hMPV) nucleic acid IVD reagentHuman metapneumovirus (hMPV) nucleic acid IVD reagentIVD General
Haemophilus influenzae culture isolate nucleic acid IVD reagentHaemophilus influenzae culture isolate nucleic acid IVD reagentIVD General
Norovirus nucleic acid IVD reagentNorovirus nucleic acid IVD reagentIVD General
Anti-CDE red blood cell grouping IVD antibodyAnti-CDE red blood cell grouping IVD antibodyIVD Annex II List B
Cytomegalovirus (CMV) nucleic acid IVD reagentCytomegalovirus (CMV) nucleic acid IVD reagentIVD Annex II List B
Rubella virus immunoglobulin G (IgG) antibody IVD reagentRubella virus immunoglobulin G (IgG) antibody IVD reagentIVD Annex II List B
Toxoplasma gondii immunoglobulin G (IgG) antibody IVD reagentToxoplasma gondii immunoglobulin G (IgG) antibody IVD reagentIVD Annex II List B
Parvovirus B19 nucleic acid IVD reagentParvovirus B19 nucleic acid IVD reagentIVD General
Respiratory syncytial virus (RSV) nucleic acid IVD reagentRespiratory syncytial virus (RSV) nucleic acid IVD reagentIVD General
HIV1/HIV2 antibody IVD reagentHIV1/HIV2 antibody IVD reagentIVD Annex II List A
Varicella-zoster virus (VZV) immunoglobulin M (IgM) antibody IVD reagentVaricella-zoster virus (VZV) immunoglobulin M (IgM) antibody IVD reagentIVD General
Rubella virus total antibody IVD reagentRubella virus total antibody IVD reagentIVD Annex II List B
Rhinovirus nucleic acid IVD reagentRhinovirus nucleic acid IVD reagentIVD General
Human parechovirus (HPeV) nucleic acid IVD reagentHuman parechovirus (HPeV) nucleic acid IVD reagentIVD General
Parasitology Controls - Inf.ImmParasitology Controls - Inf.ImmIVD General
Multiple meningitis-associated bacteria antigen IVD calibratorMultiple meningitis-associated bacteria antigen IVD calibratorIVD General
CD4 cell marker IVD antibodyCD4 cell marker IVD antibodyIVD General
Hepatitis A virus nucleic acid IVD controlHepatitis A virus nucleic acid IVD controlIVD General
T lymphocyte IVD controlT lymphocyte IVD controlIVD General
Parvovirus B19 immunoglobulin G (IgG) antibody IVD controlParvovirus B19 immunoglobulin G (IgG) antibody IVD controlIVD General
HIV1 antibody IVD controlHIV1 antibody IVD controlIVD Annex II List A
Borrelia burgdorferi immunoglobulin G (IgG) antibody IVD controlBorrelia burgdorferi immunoglobulin G (IgG) antibody IVD controlIVD General
Borrelia burgdorferi immunoglobulin M (IgM) antibody IVD controlBorrelia burgdorferi immunoglobulin M (IgM) antibody IVD controlIVD General
Parvovirus B19 immunoglobulin M (IgM) antibody IVD controlParvovirus B19 immunoglobulin M (IgM) antibody IVD controlIVD General
Rubella virus immunoglobulin M (IgM) antibody IVD reagentRubella virus immunoglobulin M (IgM) antibody IVD reagentIVD Annex II List B
Measles virus nucleic acid IVD reagentMeasles virus nucleic acid IVD reagentIVD General
Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD reagentVaricella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD reagentIVD General
Rubella Virus IgMRubella Virus IgMIVD Annex II List B
Hepatitis A virus total antibody IVD controlHepatitis A virus total antibody IVD controlIVD General
Hepatitis A virus immunoglobulin M (IgM) antibody IVD controlHepatitis A virus immunoglobulin M (IgM) antibody IVD controlIVD General
Measles virus immunoglobulin G (IgG) antibody IVD controlMeasles virus immunoglobulin G (IgG) antibody IVD controlIVD General
Mumps virus immunoglobulin G (IgG) antibody IVD controlMumps virus immunoglobulin G (IgG) antibody IVD controlIVD General
Borrelia burgdorferi immunoglobulin M (IgM) antibody IVD controlBorrelia burgdorferi immunoglobulin M (IgM) antibody IVD controlIVD General
Borrelia burgdorferi immunoglobulin G (IgG) antibody IVD controlBorrelia burgdorferi immunoglobulin G (IgG) antibody IVD controlIVD General
Negative control immunoglobulin IVDNegative control immunoglobulin IVDIVD General
Hereditary nonpolyposis colon cancer (HNPCC) IVD controlHereditary nonpolyposis colon cancer (HNPCC) IVD controlIVD General
Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD controlHerpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD controlIVD General
Multiple immunocompromised host infection-associated virus nucleic acid IVD controlMultiple immunocompromised host infection-associated virus nucleic acid IVD controlIVD Annex II List B
Multiple respiratory virus nucleic acid IVD controlMultiple respiratory virus nucleic acid IVD controlIVD General
Coxsackie B virus nucleic acid IVD controlCoxsackie B virus nucleic acid IVD controlIVD General
Zika virus nucleic acid IVD controlZika virus nucleic acid IVD controlIVD General
Plasmodium falciparum immunoglobulin G (IgG) antibody IVD controlPlasmodium falciparum immunoglobulin G (IgG) antibody IVD controlIVD General
Treponema pallidum immunoglobulin G (IgG) antibody IVD controlTreponema pallidum immunoglobulin G (IgG) antibody IVD controlIVD General
Hepatitis A virus total antibody IVD controlHepatitis A virus total antibody IVD controlIVD General
Hepatitis A virus immunoglobulin M (IgM) antibody IVD controlHepatitis A virus immunoglobulin M (IgM) antibody IVD controlIVD General
Hereditary nonpolyposis colon cancer (HNPCC) IVD controlHereditary nonpolyposis colon cancer (HNPCC) IVD controlIVD General
Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD controlHerpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD controlIVD General
Hepatitis E virus immunoglobulin G (IgG) antibody IVD controlHepatitis E virus immunoglobulin G (IgG) antibody IVD controlIVD General
Hepatitis E virus immunoglobulin M (IgM) antibody IVD controlHepatitis E virus immunoglobulin M (IgM) antibody IVD controlIVD General
Epstein-Barr virus (EBV) antigen IVD controlEpstein-Barr virus (EBV) antigen IVD controlIVD 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 M (IgM) antibody IVD controlEpstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD controlIVD General
Hepatitis C Virus - NA reagentsHepatitis C Virus - NA reagentsIVD Annex II List A