Manufacturer's Devices - DiaSorin Molecular LLC

Address:




11331 Valley View St.



Cypress

California 90630

United States


Authorised Representative/ UK Responsible Person
Name: DiaSorin Italia S.p.A. UK Branch
Address:

Central Road



Dartford

DA1 5LR

England United Kingdom




Code/Term Type
Cytomegalovirus (CMV) nucleic acid IVD calibratorCytomegalovirus (CMV) nucleic acid IVD calibratorIVD Annex II List B
Chlamydia trachomatis immunoglobulin A (IgA) antibody IVD reagentChlamydia trachomatis immunoglobulin A (IgA) antibody IVD reagentIVD Annex II List B
Chlamydia trachomatis immunoglobulin A (IgA) antibody IVD controlChlamydia trachomatis immunoglobulin A (IgA) antibody IVD controlIVD Annex II List B
Cytomegalovirus (CMV) nucleic acid IVD kit nucleic acid technique (NAT)Cytomegalovirus (CMV) nucleic acid IVD kit nucleic acid technique (NAT)IVD Annex II List B
Cytomegalovirus (CMV) nucleic acid IVD controlCytomegalovirus (CMV) nucleic acid IVD controlIVD Annex II List B
Multiple Chlamydia species immunoglobulin G (IgG) antibody IVD kit fluorescent immunoassayMultiple Chlamydia species immunoglobulin G (IgG) antibody IVD kit fluorescent immunoassayIVD Annex II List B
Multiple Chlamydia species immunoglobulin M (IgM) antibody IVD kit fluorescent immunoassayMultiple Chlamydia species immunoglobulin M (IgM) antibody IVD kit fluorescent immunoassayIVD Annex II List B
Total immunoglobulin/gamma globulin IVD reagentTotal immunoglobulin/gamma globulin IVD reagentIVD General
Total immunoglobulin M (IgM total) IVD reagentTotal immunoglobulin M (IgM total) IVD reagentIVD General
Rickettsia conorii immunoglobulin G (IgG) antibody IVD kit fluorescent immunoassayRickettsia conorii immunoglobulin G (IgG) antibody IVD kit fluorescent immunoassayIVD General
Rickettsia conorii immunoglobulin M (IgM) antibody IVD kit fluorescent immunoassayRickettsia conorii immunoglobulin M (IgM) antibody IVD kit fluorescent immunoassayIVD General
Rickettsia conorii immunoglobulin G (IgG) antibody IVD reagentRickettsia conorii immunoglobulin G (IgG) antibody IVD reagentIVD General
Multiple Rickettsia species (typhus group) immunoglobulin M (IgM) antibody IVD controlMultiple Rickettsia species (typhus group) immunoglobulin M (IgM) antibody IVD controlIVD General
Multiple Rickettsia species (spotted fever group) immunoglobulin G (IgG) antibody IVD controlMultiple Rickettsia species (spotted fever group) immunoglobulin G (IgG) antibody IVD controlIVD General
Multiple Rickettsia species (spotted fever group) immunoglobulin M (IgM) antibody IVD controlMultiple Rickettsia species (spotted fever group) immunoglobulin M (IgM) antibody IVD controlIVD General
Coxiella burnetii immunoglobulin G (IgG) antibody IVD kit fluorescent immunoassayCoxiella burnetii immunoglobulin G (IgG) antibody IVD kit fluorescent immunoassayIVD General
Coxiella burnetii immunoglobulin M (IgM) antibody IVD kit fluorescent immunoassayCoxiella burnetii immunoglobulin M (IgM) antibody IVD kit fluorescent immunoassayIVD General
Coxiella burnetii immunoglobulin G (IgG) antibody IVD reagentCoxiella burnetii immunoglobulin G (IgG) antibody IVD reagentIVD General
Coxiella burnetii immunoglobulin G (IgG) antibody IVD controlCoxiella burnetii immunoglobulin G (IgG) antibody IVD controlIVD General
Coxiella burnetii immunoglobulin M (IgM) antibody IVD controlCoxiella burnetii immunoglobulin M (IgM) antibody IVD controlIVD General
Bartonella bacilliformis immunoglobulin G (IgG) antibody IVD kit fluorescent immunoassayBartonella bacilliformis immunoglobulin G (IgG) antibody IVD kit fluorescent immunoassayIVD General
Bartonella bacilliformis immunoglobulin M (IgM) antibody IVD kit fluorescent immunoassayBartonella bacilliformis immunoglobulin M (IgM) antibody IVD kit fluorescent immunoassayIVD General
Bartonella bacilliformis immunoglobulin G (IgG) antibody IVD reagentBartonella bacilliformis immunoglobulin G (IgG) antibody IVD reagentIVD General
Bartonella bacilliformis immunoglobulin M (IgM) antibody IVD reagentBartonella bacilliformis immunoglobulin M (IgM) antibody IVD reagentIVD General
Bartonella bacilliformis immunoglobulin G (IgG) antibody IVD controlBartonella bacilliformis immunoglobulin G (IgG) antibody IVD controlIVD General
Anaplasma phagocytophilum immunoglobulin G (IgG) antibody IVD controlAnaplasma phagocytophilum immunoglobulin G (IgG) antibody IVD controlIVD General
Anaplasma phagocytophilum immunoglobulin M (IgM) antibody IVD reagentAnaplasma phagocytophilum immunoglobulin M (IgM) antibody IVD reagentIVD General
Anaplasma phagocytophilum immunoglobulin M (IgM) antibody IVD controlAnaplasma phagocytophilum immunoglobulin M (IgM) antibody IVD controlIVD General
Anaplasma phagocytophilum immunoglobulin G (IgG) antibody IVD kit fluorescent immunoassayAnaplasma phagocytophilum immunoglobulin G (IgG) antibody IVD kit fluorescent immunoassayIVD General
Anaplasma phagocytophilum immunoglobulin M (IgM) antibody IVD kit fluorescent immunoassayAnaplasma phagocytophilum immunoglobulin M (IgM) antibody IVD kit fluorescent immunoassayIVD General
Influenza A virus H1N1 subtype (swine influenza) nucleic acid IVD kit nucleic acid technique (NAT)Influenza A virus H1N1 subtype (swine influenza) nucleic acid IVD kit nucleic acid technique (NAT)IVD General
Epstein-Barr virus (EBV) nucleic acid IVD kit nucleic acid technique (NAT)Epstein-Barr virus (EBV) nucleic acid IVD kit nucleic acid technique (NAT)IVD General
Philadelphia chromosome/BCR-ABL mRNA expression IVD kit nucleic acid technique (NAT)Philadelphia chromosome/BCR-ABL mRNA expression IVD kit nucleic acid technique (NAT)IVD General
Acute promyelocytic leukaemia (APL) genetic mutation IVD kit nucleic acid technique (NAT)Acute promyelocytic leukaemia (APL) genetic mutation IVD kit nucleic acid technique (NAT)IVD General
Acute myeloid leukaemia (AML) genetic mutation IVD kit nucleic acid technique (NAT)Acute myeloid leukaemia (AML) genetic mutation IVD kit nucleic acid technique (NAT)IVD General
Non-blood cell primer/calibrator/control material IVD reagentNon-blood cell primer/calibrator/control material IVD reagentIVD General
Dengue virus nucleic acid IVD kit nucleic acid technique (NAT)Dengue virus nucleic acid IVD kit nucleic acid technique (NAT)IVD General
Multiple respiratory virus nucleic acid IVD controlMultiple respiratory virus nucleic acid IVD controlIVD General
Parvovirus B19 immunoglobulin G (IgG) antibody IVD kit enzyme immunoassay (EIA)Parvovirus B19 immunoglobulin G (IgG) antibody IVD kit enzyme immunoassay (EIA)IVD General
Parvovirus B19 immunoglobulin M (IgM) antibody IVD kit enzyme immunoassay (EIA)Parvovirus B19 immunoglobulin M (IgM) antibody IVD kit enzyme immunoassay (EIA)IVD General
West Nile virus immunoglobulin G (IgG) antibody IVD kit enzyme immunoassay (EIA)West Nile virus immunoglobulin G (IgG) antibody IVD kit enzyme immunoassay (EIA)IVD General
West Nile virus immunoglobulin M (IgM) antibody IVD kit fluorescent immunoassayWest Nile virus immunoglobulin M (IgM) antibody IVD kit fluorescent immunoassayIVD General
Wash/cleaning solution IVD automated/semi-automated systemWash/cleaning solution IVD automated/semi-automated systemIVD General
Herpes simplex virus 1 (HSV1) immunoglobulin G (IgG) antibody IVD kit enzyme immunoassay (EIA)Herpes simplex virus 1 (HSV1) immunoglobulin G (IgG) antibody IVD kit enzyme immunoassay (EIA)IVD General
Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD kit enzyme immunoassay (EIA)Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD kit enzyme immunoassay (EIA)IVD General
Dengue virus immunoglobulin G (IgG) antibody IVD kit enzyme immunoassay (EIA)Dengue virus immunoglobulin G (IgG) antibody IVD kit enzyme immunoassay (EIA)IVD General
Dengue virus immunoglobulin M (IgM) antibody IVD kit enzyme immunoassay (EIA)Dengue virus immunoglobulin M (IgM) antibody IVD kit enzyme immunoassay (EIA)IVD General
Dengue virus NS1 antigen IVD kit enzyme immunoassay (EIA)Dengue virus NS1 antigen IVD kit enzyme immunoassay (EIA)IVD General
Hantavirus immunoglobulin G (IgG) antibody IVD kit enzyme immunoassay (EIA)Hantavirus immunoglobulin G (IgG) antibody IVD kit enzyme immunoassay (EIA)IVD General
Hantavirus immunoglobulin M (IgM) antibody IVD kit enzyme immunoassay (EIA)Hantavirus immunoglobulin M (IgM) antibody IVD kit enzyme immunoassay (EIA)IVD General
Multiple respiratory virus nucleic acid IVD kit nucleic acid technique (NAT)Multiple respiratory virus nucleic acid IVD kit nucleic acid technique (NAT)IVD General
Multiple Human herpesvirus nucleic acid IVD kit nucleic acid technique (NAT)Multiple Human herpesvirus nucleic acid IVD kit nucleic acid technique (NAT)IVD General
JC virus (JCV) antigen IVD kit enzyme immunoassay (EIA)JC virus (JCV) antigen IVD kit enzyme immunoassay (EIA)IVD General
Clostridium difficile antigen IVD controlClostridium difficile antigen IVD controlIVD General
Clostridium difficile nucleic acid IVD kit nucleic acid technique (NAT)Clostridium difficile nucleic acid IVD kit nucleic acid technique (NAT)IVD General
Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD kit nucleic acid technique (NAT)Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD kit nucleic acid technique (NAT)IVD General
Multiple-type sexually transmitted pathogen nucleic acid IVD controlMultiple-type sexually transmitted pathogen nucleic acid IVD controlIVD General
Beta-haemolytic Group A Streptococcus nucleic acid IVD kit nucleic acid technique (NAT)Beta-haemolytic Group A Streptococcus nucleic acid IVD kit nucleic acid technique (NAT)IVD General
Beta-haemolytic Group A Streptococcus nucleic acid IVD controlBeta-haemolytic Group A Streptococcus nucleic acid IVD controlIVD General
Bordetella pertussis nucleic acid IVD kit nucleic acid technique (NAT)Bordetella pertussis nucleic acid IVD kit nucleic acid technique (NAT)IVD General
Thermal cycler nucleic acid amplification analyser IVD laboratoryThermal cycler nucleic acid amplification analyser IVD laboratoryIVD General
Clostridium difficile nucleic acid IVD reagentClostridium difficile nucleic acid IVD reagentIVD General
Varicella-zoster virus (VZV) nucleic acid IVD kit nucleic acid technique (NAT)Varicella-zoster virus (VZV) nucleic acid IVD kit nucleic acid technique (NAT)IVD General
Varicella-zoster virus (VZV) nucleic acid IVD controlVaricella-zoster virus (VZV) nucleic acid IVD controlIVD General
Beta-haemolytic Group B Streptococcus nucleic acid IVD kit nucleic acid technique (NAT)Beta-haemolytic Group B Streptococcus nucleic acid IVD kit nucleic acid technique (NAT)IVD General
Beta-haemolytic Group B Streptococcus nucleic acid IVD controlBeta-haemolytic Group B Streptococcus nucleic acid IVD controlIVD General
Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD kit immunoblotHerpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD kit immunoblotIVD General
Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD kit immunoblotHerpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD kit immunoblotIVD General