Manufacturer's Devices - LGC Clinical Diagnostics Inc.

Address:




37 Birch Street



Milford

Massachusetts 01757

United States


Authorised Representative/ UK Responsible Person
Name: QCS International LTD.
Address:

Suite 9 Cumbernauld Business Park

Wardpark Road

Cumbernauld

North Lanarkshire G67 3JZ

Scotland United Kingdom




Code/Term Type
Negative control immunoglobulin IVDNegative control immunoglobulin IVDIVD Annex II List A
Multiple blood-borne virus antigen/antibody IVD controlMultiple blood-borne virus antigen/antibody IVD controlIVD Annex II List A
Hepatitis B virus antigen/antibody marker IVD controlHepatitis B virus antigen/antibody marker IVD controlIVD Annex II List A
HIV1 antigen IVD controlHIV1 antigen 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
Hepatitis B virus core immunoglobulin G (IgG) antibody IVD controlHepatitis B virus core immunoglobulin G (IgG) antibody IVD controlIVD 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 antigen IVD controlHepatitis B virus surface antigen IVD controlIVD Annex II List A
Human T-cell lymphotrophic virus 2 (HTLV2) nucleic acid IVD controlHuman T-cell lymphotrophic virus 2 (HTLV2) nucleic acid IVD controlIVD Annex II List A
Hepatitis C virus nucleic acid IVD controlHepatitis C virus nucleic acid IVD controlIVD Annex II List A
HIV1 nucleic acid IVD controlHIV1 nucleic acid IVD controlIVD Annex II List A
Hepatitis B virus nucleic acid IVD controlHepatitis B virus nucleic acid IVD controlIVD Annex II List A
PCR/NAT negative control IVDPCR/NAT negative control IVDIVD 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
Cytomegalovirus (CMV) antigen IVD controlCytomegalovirus (CMV) antigen 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 M (IgM) antibody IVD controlToxoplasma gondii 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
Multiple infectious organism/newborn TORCH screen IVD controlMultiple infectious organism/newborn TORCH screen IVD controlIVD Annex II List B
Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD controlEpstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD controlIVD Annex II List B
Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD controlEpstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD controlIVD Annex II List B
Multiple-type sexually transmitted pathogen nucleic acid IVD controlMultiple-type sexually transmitted pathogen nucleic acid IVD controlIVD Annex II List B
Negative control immunoglobulin IVDNegative control immunoglobulin IVDIVD Annex II List B
Treponema pallidum reagin antibody IVD controlTreponema pallidum reagin antibody IVD controlIVD General
Hepatitis A virus immunoglobulin G (IgG) antibody IVD controlHepatitis A virus immunoglobulin G (IgG) antibody IVD controlIVD General
Treponema pallidum immunoglobulin G (IgG) antibody IVD controlTreponema pallidum immunoglobulin G (IgG) antibody IVD controlIVD General
SARS-CoV-2 total antibody IVD controlSARS-CoV-2 total antibody IVD controlIVD General
SARS-CoV-2 immunoglobulin G (IgG) antibody IVD controlSARS-CoV-2 immunoglobulin G (IgG) antibody IVD controlIVD General
SARS-CoV-2 nucleic acid IVD controlSARS-CoV-2 nucleic acid IVD controlIVD General
PCR/NAT negative control IVDPCR/NAT negative control IVDIVD General
Human papillomavirus (HPV) nucleic acid IVD controlHuman papillomavirus (HPV) nucleic acid IVD controlIVD General
Trypanosoma cruzi total antibody IVD controlTrypanosoma cruzi total antibody IVD controlIVD General
Clostridium difficile nucleic acid IVD controlClostridium difficile nucleic acid 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
Ebola virus nucleic acid IVD controlEbola virus nucleic acid IVD controlIVD 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 G (IgG) antibody IVD controlEpstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD controlIVD General
Multiple respiratory virus nucleic acid IVD controlMultiple respiratory virus nucleic acid IVD controlIVD General
Hepatitis A virus immunoglobulin M (IgM) antibody IVD controlHepatitis A virus immunoglobulin M (IgM) antibody IVD controlIVD General
Treponema pallidum reagin antibody IVD controlTreponema pallidum reagin antibody IVD controlIVD General