Manufacturer's Devices - DiaSorin Italia S.p.A.

Address:




DiaSorin Italia S.p.A.

Via Crescentino SALUGGIA

VC

Piemonte 13040

Italy


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
Hepatitis B virus surface total antibody IVD kit chemiluminescent immunoassayHepatitis B virus surface total antibody IVD kit chemiluminescent immunoassay Conformity Assessment Certificate ExpiredIVD Annex II List A
Hepatitis B virus surface total antibody IVD controlHepatitis B virus surface total antibody IVD control Conformity Assessment Certificate ExpiredIVD Annex II List A
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 kit chemiluminescent immunoassayHepatitis E virus immunoglobulin M (IgM) antibody IVD kit chemiluminescent immunoassayIVD General
Hepatitis E virus immunoglobulin M (IgM) antibody IVD controlHepatitis E virus immunoglobulin M (IgM) antibody IVD controlIVD General
Multiple antinuclear antibody (ANA) screening IVD kit chemiluminescent immunoassayMultiple antinuclear antibody (ANA) screening IVD kit chemiluminescent immunoassayIVD General
Multiple antinuclear antibody (ANA) screening IVD controlMultiple antinuclear antibody (ANA) screening IVD controlIVD General
Trypanosoma cruzi total antibody IVD kit chemiluminescent immunoassayTrypanosoma cruzi total antibody IVD kit chemiluminescent immunoassayIVD General
Hepatitis E virus immunoglobulin G (IgG) antibody IVD kit chemiluminescent immunoassayHepatitis E virus immunoglobulin G (IgG) antibody IVD kit chemiluminescent immunoassayIVD General
Multiple Borrelia species immunoglobulin G (IgG)/IgM antibody IVD kit chemiluminescent immunoassayMultiple Borrelia species immunoglobulin G (IgG)/IgM antibody IVD kit chemiluminescent immunoassayIVD General
Multiple Borrelia species immunoglobulin G (IgG)/IgM antibody IVD controlMultiple Borrelia species immunoglobulin G (IgG)/IgM antibody IVD controlIVD General
Hepatitis A virus total antibody IVD kit chemiluminescent immunoassayHepatitis A virus total antibody IVD kit chemiluminescent immunoassayIVD General
Hepatitis A virus total antibody IVD controlHepatitis A virus total antibody IVD controlIVD General
Parvovirus B19 immunoglobulin G (IgG) antibody IVD kit chemiluminescent immunoassayParvovirus B19 immunoglobulin G (IgG) antibody IVD kit chemiluminescent immunoassayIVD General
Parvovirus B19 immunoglobulin G (IgG) antibody IVD controlParvovirus B19 immunoglobulin G (IgG) antibody IVD controlIVD General
Parvovirus B19 immunoglobulin M (IgM) antibody IVD kit chemiluminescent immunoassayParvovirus B19 immunoglobulin M (IgM) antibody IVD kit chemiluminescent immunoassayIVD General
Parvovirus B19 immunoglobulin M (IgM) antibody IVD controlParvovirus B19 immunoglobulin M (IgM) antibody IVD controlIVD General
Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD kit chemiluminescent immunoassayBorrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD kit chemiluminescent immunoassayIVD General
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
Anticardiolipin antibody IVD kit chemiluminescent immunoassayAnticardiolipin antibody IVD kit chemiluminescent immunoassayIVD General
Anticardiolipin antibody IVD controlAnticardiolipin antibody IVD controlIVD General
Trypanosoma cruzi total antibody IVD controlTrypanosoma cruzi total antibody IVD controlIVD General
Dehydroepiandrosterone sulfate (DHEAS) IVD controlDehydroepiandrosterone sulfate (DHEAS) IVD controlIVD General
DoublestrandedDNAantibody (anti-dsDNA) IVD kit chemiluminescent immunoassayDoublestrandedDNAantibody (anti-dsDNA) IVD kit chemiluminescent immunoassayIVD General
Dehydroepiandrosterone sulfate (DHEAS) IVD kit chemiluminescent immunoassayDehydroepiandrosterone sulfate (DHEAS) IVD kit chemiluminescent immunoassayIVD General
Double stranded DNA antibody (anti-dsDNA) IVD controlDouble stranded DNA antibody (anti-dsDNA) IVD controlIVD General
Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD controlEpstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD controlIVD General
Multiple extractable nuclear antigen antibody (anti-ENA) screening IVD kit chemiluminescent immunoassayMultiple extractable nuclear antigen antibody (anti-ENA) screening IVD kit chemiluminescent immunoassayIVD General
Multiple extractable nuclear antigen antibody (anti-ENA) screening IVD controlMultiple extractable nuclear antigen antibody (anti-ENA) screening IVD controlIVD General
Hepatitis A virus immunoglobulin M (IgM) antibody IVD controlHepatitis A virus immunoglobulin M (IgM) antibody IVD controlIVD General
Hepatitis A virus immunoglobulin M (IgM) antibody IVD kit chemiluminescent immunoassayHepatitis A virus immunoglobulin M (IgM) antibody IVD kit chemiluminescent immunoassayIVD General
Human growth hormone (HGH) IVD kit chemiluminescent immunoassayHuman growth hormone (HGH) IVD kit chemiluminescent immunoassayIVD General
Human growth hormone (HGH) IVD controlHuman growth hormone (HGH) IVD controlIVD General
Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD kit chemiluminescent immunoassayHerpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD kit chemiluminescent immunoassayIVD 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
Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin M (IgM) antibody IVD kit chemiluminescent immunoassayHerpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin M (IgM) antibody IVD kit chemiluminescent immunoassayIVD General
Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin M (IgM) antibody IVD controlHerpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin M (IgM) antibody IVD controlIVD General
Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD kit chemiluminescent immunoassayHerpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD kit chemiluminescent immunoassayIVD General
Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD controlHerpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD controlIVD General
Insulin IVD kit chemiluminescent immunoassayInsulin IVD kit chemiluminescent immunoassayIVD General
Insulin IVD controlInsulin IVD controlIVD General
Measles virus immunoglobulin G (IgG) antibody IVD kit chemiluminescent immunoassayMeasles virus immunoglobulin G (IgG) antibody IVD kit chemiluminescent immunoassayIVD General
Measles virus immunoglobulin G (IgG) antibody IVD controlMeasles virus immunoglobulin G (IgG) antibody IVD controlIVD General
Measles virus immunoglobulin M (IgM) antibody IVD kit chemiluminescent immunoassayMeasles virus immunoglobulin M (IgM) antibody IVD kit chemiluminescent immunoassayIVD General
Measles virus immunoglobulin M (IgM) antibody IVD controlMeasles virus immunoglobulin M (IgM) antibody IVD controlIVD General
Mumps virus immunoglobulin G (IgG) antibody IVD kit chemiluminescent immunoassayMumps virus immunoglobulin G (IgG) antibody IVD kit chemiluminescent immunoassayIVD General
Mumps virus immunoglobulin G (IgG) antibody IVD controlMumps virus immunoglobulin G (IgG) antibody IVD controlIVD General
Mumps virus immunoglobulin M (IgM) antibody IVD kit chemiluminescent immunoassayMumps virus immunoglobulin M (IgM) antibody IVD kit chemiluminescent immunoassayIVD General
Mumps virus immunoglobulin M (IgM) antibody IVD controlMumps virus immunoglobulin M (IgM) antibody IVD controlIVD General
Mycoplasma pneumoniae immunoglobulin G (IgG) antibody IVD kit chemiluminescent immunoassayMycoplasma pneumoniae immunoglobulin G (IgG) antibody IVD kit chemiluminescent immunoassayIVD General
Mycoplasma pneumoniae immunoglobulin G (IgG) antibody IVD controlMycoplasma pneumoniae immunoglobulin G (IgG) antibody IVD controlIVD General
Mycoplasma pneumoniae immunoglobulinM (IgM) antibody IVD kit chemiluminescent immunoassayMycoplasma pneumoniae immunoglobulinM (IgM) antibody IVD kit chemiluminescent immunoassayIVD General
Mycoplasma pneumoniae immunoglobulin M (IgM) antibody IVD controlMycoplasma pneumoniae immunoglobulin M (IgM) antibody IVD controlIVD General
Treponema pallidum total antibody IVD kit chemiluminescent immunoassayTreponema pallidum total antibody IVD kit chemiluminescent immunoassayIVD General
Treponema pallidum total antibody IVD controlTreponema pallidum total antibody IVD controlIVD General
Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD kit chemiluminescent immunoassayVaricella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD kit chemiluminescent immunoassayIVD General
Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD controlVaricella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD controlIVD General
Varicella-zoster virus (VZV) immunoglobulin M (IgM) antibody IVD kit chemiluminescent immunoassayVaricella-zoster virus (VZV) immunoglobulin M (IgM) antibody IVD kit chemiluminescent immunoassayIVD General
Varicella-zoster virus (VZV) immunoglobulin M (IgM) antibody IVD controlVaricella-zoster virus (VZV) immunoglobulin M (IgM) antibody IVD controlIVD General
Renin IVD kit chemiluminescent immunoassayRenin IVD kit chemiluminescent immunoassayIVD General
Renin IVD controlRenin IVD controlIVD General
Bordetella pertussis immunoglobulin G (IgG) antibody IVD kit chemiluminescent immunoassayBordetella pertussis immunoglobulin G (IgG) antibody IVD kit chemiluminescent immunoassayIVD General
Bordetella pertussis immunoglobulin G (IgG) antibody IVD controlBordetella pertussis immunoglobulin G (IgG) antibody IVD controlIVD General
Bordetella pertussis immunoglobulin A (IgA) antibody IVD controlBordetella pertussis immunoglobulin A (IgA) antibody IVD controlIVD General
Procalcitonin (PCT) IVD kit chemiluminescent immunoassayProcalcitonin (PCT) IVD kit chemiluminescent immunoassayIVD General
Procalcitonin (PCT) IVD controlProcalcitonin (PCT) IVD controlIVD General
Procalcitonin (PCT) IVD reagentProcalcitonin (PCT) IVD reagentIVD General
Intact fibroblast growth factor 23 (iFGF23) IVD kit chemiluminescent immunoassayIntact fibroblast growth factor 23 (iFGF23) IVD kit chemiluminescent immunoassayIVD General
Interferon IVD kit chemiluminescent immunoassayInterferon IVD kit chemiluminescent immunoassayIVD General
Interferon gamma release IVD controlInterferon gamma release IVD controlIVD General
Hepatitis A virus total antibody IVD kit enzyme immunoassay (EIA)Hepatitis A virus total antibody IVD kit enzyme immunoassay (EIA)IVD General
Hepatitis A virus immunoglobulin M (IgM) antibody IVD kit enzyme immunoassay (EIA)Hepatitis A virus immunoglobulin M (IgM) antibody IVD kit enzyme immunoassay (EIA)IVD General
Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD kit chemiluminescent immunoassayEpstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD kit chemiluminescent immunoassayIVD General
Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD kit chemiluminescent immunoassayEpstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD kit chemiluminescent immunoassayIVD General
Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD controlEpstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD controlIVD General
Thyroid stimulating hormone (TSH) IVD kit chemiluminescent immunoassayThyroid stimulating hormone (TSH) 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
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
Thyroglobulin antibody IVD kit chemiluminescent immunoassayThyroglobulin antibody IVD kit chemiluminescent immunoassayIVD General
Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD kit chemiluminescent immunoassayThyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD kit chemiluminescent immunoassayIVD General
Thyroglobulin IVD kit chemiluminescent immunoassayThyroglobulin IVD kit chemiluminescent immunoassayIVD General
Luteinizing hormone (LH) IVD kit chemiluminescent immunoassayLuteinizing hormone (LH) 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
Prolactin IVD kit chemiluminescent immunoassayProlactin IVD kit chemiluminescent immunoassayIVD General
Total cortisol IVD kit chemiluminescent immunoassayTotal cortisol IVD kit chemiluminescent immunoassayIVD General
Adrenocorticotropic hormone (ACTH) IVD kit chemiluminescent immunoassayAdrenocorticotropic hormone (ACTH) IVD kit chemiluminescent immunoassayIVD General
Insulin-like growth factor I (IGF1) IVD kit chemiluminescent immunoassayInsulin-like growth factor I (IGF1) IVD kit chemiluminescent immunoassayIVD General
Carcinoembryonic antigen (CEA) IVD kit chemiluminescent immunoassayCarcinoembryonic antigen (CEA) IVD kit chemiluminescent immunoassayIVD General
Cancer antigen 15-3 (CA15-3) IVD kit chemiluminescent immunoassayCancer antigen 15-3 (CA15-3) IVD kit chemiluminescent immunoassayIVD General
Cancerantigen19-9 (CA19-9) IVD kit chemiluminescent immunoassayCancerantigen19-9 (CA19-9) IVD kit chemiluminescent immunoassayIVD General
Cancer antigen 125 (CA125) IVD kit chemiluminescent immunoassayCancer antigen 125 (CA125) IVD kit chemiluminescent immunoassayIVD General
Alpha-fetoprotein (AFP) IVD kit chemiluminescent immunoassayAlpha-fetoprotein (AFP) IVD kit chemiluminescent immunoassayIVD General
FerritinIVD kit chemiluminescent immunoassayFerritinIVD kit chemiluminescent immunoassayIVD General
Beta-2-microglobulin IVD kit chemiluminescent immunoassayBeta-2-microglobulin IVD kit chemiluminescent immunoassayIVD General
Neuron-specific enolase (NSE) IVD kit chemiluminescent immunoassayNeuron-specific enolase (NSE) IVD kit chemiluminescent immunoassayIVD General
S100-beta (S100-B) protein IVD kit chemiluminescent immunoassayS100-beta (S100-B) protein IVD kit chemiluminescent immunoassayIVD General
Tissue transglutaminase antibody IVD kit chemiluminescent immunoassayTissue transglutaminase antibody IVD kit chemiluminescent immunoassayIVD General
C-peptide IVD kit chemiluminescent immunoassayC-peptide IVD kit chemiluminescent immunoassayIVD General
Multiple thyroid marker IVD controlMultiple thyroid marker IVD controlIVD General
Multiple tissue-associated protein/tumour marker IVD controlMultiple tissue-associated protein/tumour marker IVD controlIVD General
Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD controlThyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD controlIVD General
Thyroglobulin antibody IVD controlThyroglobulin antibody IVD controlIVD General
Thyroglobulin IVD controlThyroglobulin IVD controlIVD General
Adrenocorticotropic hormone (ACTH) IVD controlAdrenocorticotropic hormone (ACTH) IVD controlIVD General
Insulin-like growth factor I (IGF1) IVD controlInsulin-like growth factor I (IGF1) IVD controlIVD General
Tissue polypeptide antigen IVD controlTissue polypeptide antigen IVD controlIVD General
Neuron-specific enolase (NSE) IVD controlNeuron-specific enolase (NSE) IVD controlIVD General
S100-beta (S100-B) protein IVD calibratorS100-beta (S100-B) protein IVD calibratorIVD General
S100-beta (S100-B) protein IVD controlS100-beta (S100-B) protein IVD controlIVD General
Ferritin IVD controlFerritin IVD controlIVD General
Tissue transglutaminase antibody IVD controlTissue transglutaminase antibody IVD controlIVD General
Buffered sample diluent IVDBuffered sample diluent IVDIVD General
Thyroglobulin neutralizing antibody IVD reagentThyroglobulin neutralizing antibody IVD reagentIVD General
Chemiluminescent immunoassay oxidizing reagent IVDChemiluminescent immunoassay oxidizing reagent IVDIVD General
Optical laboratory instrument performance standard calibrator/control IVD single-useOptical laboratory instrument performance standard calibrator/control IVD single-useIVD General
Tissue polypeptide antigen IVD kit chemiluminescent immunoassayTissue polypeptide antigen IVD kit chemiluminescent immunoassayIVD General
Bordetella pertussis immunoglobulin A (IgA) antibody IVD kit chemiluminescent immunoassayBordetella pertussis immunoglobulin A (IgA) antibody IVD kit chemiluminescent immunoassayIVD General
Buffered wash solution IVDBuffered wash solution IVDIVD General
Interferon gamma release IVD reagentInterferon gamma release IVD reagentIVD General
Neonatal thyroid stimulating hormone (neonatal TSH) IVD controlNeonatal thyroid stimulating hormone (neonatal TSH) IVD controlIVD General
Laboratory instrument/analyser application software IVDLaboratory instrument/analyser application software IVDIVD General
Enzyme immunoassay (EIA) analyser IVD semi-automatedEnzyme immunoassay (EIA) analyser IVD semi-automatedIVD General
SARS-CoV-2 antigen IVD controlSARS-CoV-2 antigen IVD controlIVD General
SARS-CoV-2 immunoglobulin M (IgM) antibody IVD kit chemiluminescent immunoassaySARS-CoV-2 immunoglobulin M (IgM) antibody IVD kit chemiluminescent immunoassayIVD General
SARS-CoV-2 immunoglobulin M (IgM) antibody IVD controlSARS-CoV-2 immunoglobulin M (IgM) 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
Hepatitis B virus surface antigen IVD controlHepatitis B virus surface antigen IVD control Conformity Assessment Certificate ExpiredIVD Annex II List A
Hepatitis B virus surface antigen neutralization IVD kit chemiluminescent immunoassayHepatitis B virus surface antigen neutralization IVD kit chemiluminescent immunoassay Conformity Assessment Certificate ExpiredIVD Annex II List A
Hepatitis B virus surface antigen IVD kit chemiluminescent immunoassayHepatitis B virus surface antigen IVD kit chemiluminescent immunoassay Conformity Assessment Certificate ExpiredIVD 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 immunoassay Conformity Assessment Certificate ExpiredIVD 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 control Conformity Assessment Certificate ExpiredIVD Annex II List A
Free (unbound) prostate specific antigen (fPSA) IVD controlFree (unbound) prostate specific antigen (fPSA) IVD control Conformity Assessment Certificate ExpiredIVD Annex II List B
Rubellavirus immunoglobulin G (IgG) antibody IVD kit chemiluminescent immunoassayRubellavirus immunoglobulin G (IgG) antibody IVD kit chemiluminescent immunoassay Conformity Assessment Certificate ExpiredIVD Annex II List B
Cytomegalovirus (CMV) immunoglobulin M (IgM) antibody IVD controlCytomegalovirus (CMV) immunoglobulin M (IgM) antibody IVD control Conformity Assessment Certificate ExpiredIVD Annex II List B
Cytomegalovirus (CMV) immunoglobulin M (IgM) antibody IVD kit chemiluminescent immunoassayCytomegalovirus (CMV) immunoglobulin M (IgM) antibody IVD kit chemiluminescent immunoassay Conformity Assessment Certificate ExpiredIVD Annex II List B
Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD controlCytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD control Conformity Assessment Certificate ExpiredIVD Annex II List B
Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD kit chemiluminescent immunoassayCytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD kit chemiluminescent immunoassay Conformity Assessment Certificate ExpiredIVD Annex II List B
Chlamydia trachomatis immunoglobulin G (IgG) antibody IVD controlChlamydia trachomatis immunoglobulin G (IgG) antibody IVD control Conformity Assessment Certificate ExpiredIVD Annex II List B
Chlamydia trachomatis immunoglobulin G (IgG) antibody IVD kit chemiluminescent immunoassayChlamydia trachomatis immunoglobulin G (IgG) antibody IVD kit chemiluminescent immunoassay Conformity Assessment Certificate ExpiredIVD Annex II List B
Chlamydia trachomatis immunoglobulin A (IgA) antibody IVD controlChlamydia trachomatis immunoglobulin A (IgA) antibody IVD control Conformity Assessment Certificate ExpiredIVD Annex II List B
Rubella virus immunoglobulin G (IgG) antibody IVD controlRubella virus immunoglobulin G (IgG) antibody IVD control Conformity Assessment Certificate ExpiredIVD Annex II List B
Rubella virus immunoglobulin M (IgM) antibody IVD kit chemiluminescent immunoassayRubella virus immunoglobulin M (IgM) antibody IVD kit chemiluminescent immunoassay Conformity Assessment Certificate ExpiredIVD Annex II List B
Total prostate specific antigen (tPSA) IVD controlTotal prostate specific antigen (tPSA) IVD control Conformity Assessment Certificate ExpiredIVD Annex II List B
Free (unbound) prostate specific antigen (fPSA) IVD kit chemiluminescent immunoassayFree (unbound) prostate specific antigen (fPSA) IVD kit chemiluminescent immunoassay Conformity Assessment Certificate ExpiredIVD Annex II List B
Total prostate specific antigen (tPSA) IVD kit chemiluminescent immunoassayTotal prostate specific antigen (tPSA) IVD kit chemiluminescent immunoassay Conformity Assessment Certificate ExpiredIVD Annex II List B
Toxoplasma gondii immunoglobulin M (IgM) antibody IVD controlToxoplasma gondii immunoglobulin M (IgM) antibody IVD control Conformity Assessment Certificate ExpiredIVD Annex II List B
Toxoplasma gondii immunoglobulin M (IgM) antibody IVD kit chemiluminescent immunoassayToxoplasma gondii immunoglobulin M (IgM) antibody IVD kit chemiluminescent immunoassay Conformity Assessment Certificate ExpiredIVD Annex II List B
Toxoplasma gondii immunoglobulin G (IgG) antibody IVD controlToxoplasma gondii immunoglobulin G (IgG) antibody IVD control Conformity Assessment Certificate ExpiredIVD Annex II List B
Toxoplasma gondii immunoglobulin G (IgG) antibody IVD kit chemiluminescent immunoassayToxoplasma gondii immunoglobulin G (IgG) antibody IVD kit chemiluminescent immunoassay Conformity Assessment Certificate ExpiredIVD Annex II List B
Rubella virus immunoglobulin M (IgM) antibody IVD controlRubella virus immunoglobulin M (IgM) antibody IVD control Conformity Assessment Certificate ExpiredIVD Annex II List B
Hepatitis B virus core immunoglobulin M (IgM) antibody IVD kit enzyme immunoassay (EIA)Hepatitis B virus core immunoglobulin M (IgM) antibody IVD kit enzyme immunoassay (EIA) Conformity Assessment Certificate ExpiredIVD Annex II List A
Hepatitis B virus e-antigen total antibody IVD kit enzyme immunoassay (EIA)Hepatitis B virus e-antigen total antibody IVD kit enzyme immunoassay (EIA) Conformity Assessment Certificate ExpiredIVD Annex II List A
Hepatitis B virus surface total antibody IVD reagentHepatitis B virus surface total antibody IVD reagent Conformity Assessment Certificate ExpiredIVD Annex II List A
Hepatitis B virus core total antibody IVD controlHepatitis B virus core total antibody IVD control Conformity Assessment Certificate ExpiredIVD Annex II List A
Hepatitis B virus e-antigen IVD controlHepatitis B virus e-antigen IVD control Conformity Assessment Certificate ExpiredIVD 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 immunoassay Conformity Assessment Certificate ExpiredIVD Annex II List A
Hepatitis B virus core immunoglobulin M (IgM) antibody IVD controlHepatitis B virus core immunoglobulin M (IgM) antibody IVD control Conformity Assessment Certificate ExpiredIVD Annex II List A
Hepatitis C virus immunoglobulin G (IgG) antibody IVD kit chemiluminescent immunoassayHepatitis C virus immunoglobulin G (IgG) antibody IVD kit chemiluminescent immunoassay Conformity Assessment Certificate ExpiredIVD Annex II List A
Hepatitis C virus immunoglobulin G (IgG) antibody IVD controlHepatitis C virus immunoglobulin G (IgG) antibody IVD control Conformity Assessment Certificate ExpiredIVD Annex II List A
HIV1/HIV2 antigen/antibody IVD controlHIV1/HIV2 antigen/antibody IVD control Conformity Assessment Certificate ExpiredIVD Annex II List A
HIV1/HIV2 antigen/antibody IVD kit chemiluminescent immunoassayHIV1/HIV2 antigen/antibody IVD kit chemiluminescent immunoassay Conformity Assessment Certificate ExpiredIVD Annex II List A
Hepatitis B virus core total antibody IVD kit chemiluminescent immunoassayHepatitis B virus core total antibody IVD kit chemiluminescent immunoassay Conformity Assessment Certificate ExpiredIVD Annex II List A
Hepatitis B virus e-antigen IVD kit chemiluminescent immunoassayHepatitis B virus e-antigen IVD kit chemiluminescent immunoassay Conformity Assessment Certificate ExpiredIVD Annex II List A
Hepatitis B virus surface total antibody IVD kit enzyme immunoassay (EIA)Hepatitis B virus surface total antibody IVD kit enzyme immunoassay (EIA) Conformity Assessment Certificate ExpiredIVD Annex II List A
Hepatitis B virus core total antibody IVD kit enzyme immunoassay (EIA)Hepatitis B virus core total antibody IVD kit enzyme immunoassay (EIA) Conformity Assessment Certificate ExpiredIVD Annex II List A
Hepatitis B virus e-antigen IVD kit enzyme immunoassay (EIA)Hepatitis B virus e-antigen IVD kit enzyme immunoassay (EIA) Conformity Assessment Certificate ExpiredIVD Annex II List A
Hepatitis D virus total antibody IVD controlHepatitis D virus total antibody IVD control Conformity Assessment Certificate ExpiredIVD Annex II List A
Hepatitis D virus total antibody IVD kit chemiluminescent immunoassayHepatitis D virus total antibody IVD kit chemiluminescent immunoassay Conformity Assessment Certificate ExpiredIVD Annex II List A
Hepatitis B virus e-antigen total antibody IVD controlHepatitis B virus e-antigen total antibody IVD control Conformity Assessment Certificate ExpiredIVD Annex II List A
Hepatitis B virus e-antigen total antibody IVD kit chemiluminescent immunoassayHepatitis B virus e-antigen total antibody IVD kit chemiluminescent immunoassay Conformity Assessment Certificate ExpiredIVD Annex II List A
Chlamydia trachomatis immunoglobulin A (IgA) antibody IVD kit chemiluminescent immunoassayChlamydia trachomatis immunoglobulin A (IgA) antibody IVD kit chemiluminescent immunoassay Conformity Assessment Certificate ExpiredIVD Annex II List B
Hepatitis B virus surface antigen IVD reagentHepatitis B virus surface antigen IVD reagentClass A
Enzyme immunoassay (EIA) analyser IVDEnzyme immunoassay (EIA) analyser IVDIVD General
Assay container IVD single-useAssay container IVD single-useClass A
Assay container liner IVDAssay container liner IVDClass A
Chemiluminescent immunoassay analyser IVDChemiluminescent immunoassay analyser IVDClass A
Thermal cycler nucleic acid amplification analyser IVD laboratoryThermal cycler nucleic acid amplification analyser IVD laboratoryIVD General
Viral inactivation buffer IVDViral inactivation buffer IVDClass A
Wash/cleaning solution IVD automated/semi-automated systemWash/cleaning solution IVD automated/semi-automated systemClass A
Wash/cleaning solution IVD automated/semi-automated systemWash/cleaning solution IVD automated/semi-automated systemClass A
Wash/cleaning solution IVD automated/semi-automated systemWash/cleaning solution IVD automated/semi-automated systemClass A
Wash/cleaning solution IVD automated/semi-automated systemWash/cleaning solution IVD automated/semi-automated systemClass A
Wash/cleaning solution IVD automated/semi-automated systemWash/cleaning solution IVD automated/semi-automated systemClass A
Wash/cleaning solution IVD automated/semi-automated systemWash/cleaning solution IVD automated/semi-automated systemClass A
Wash/cleaning solution IVD automated/semi-automated systemWash/cleaning solution IVD automated/semi-automated systemClass A
Wash/cleaning solution IVD automated/semi-automated systemWash/cleaning solution IVD automated/semi-automated systemClass A