Manufacturer's Devices - DIALAB GmbH

Address:




IZ NOE-Sued Hondastrasse

Objekt M55 IZ NOE-Sued

Wr. Neudorf

2351

Austria


Authorised Representative/ UK Responsible Person
Name: Alpha Laboratories Ltd
Address:

Unit 40 Parham Drive



Eastleigh

Hampshire SO50 4NU

United Kingdom




Code/Term Type
Multiple Chlamydia species antigen IVD kit rapid ICT clinicalMultiple Chlamydia species antigen IVD kit rapid ICT clinicalIVD Annex II List B
Total prostate specific antigen (tPSA) IVD kit enzyme immunoassay (EIA)Total prostate specific antigen (tPSA) IVD kit enzyme immunoassay (EIA)IVD Annex II List B
Alpha-1-acid glycoprotein (orosomucoid) IVD kit nephelometry/turbidimetryAlpha-1-acid glycoprotein (orosomucoid) IVD kit nephelometry/turbidimetryIVD General
Beta-haemolytic Group A Streptococcus antigen IVD kit rapid ICT clinicalBeta-haemolytic Group A Streptococcus antigen IVD kit rapid ICT clinicalIVD General
Treponema pallidum immunoglobulin G (IgG)/IgM antibody IVD kit rapid ICT clinicalTreponema pallidum immunoglobulin G (IgG)/IgM antibody IVD kit rapid ICT clinicalIVD General
Faecal occult blood IVD kit rapid ICT clinicalFaecal occult blood IVD kit rapid ICT clinicalIVD General
Total bile acid IVD reagentTotal bile acid IVD reagentIVD General
Total bile acid IVD calibratorTotal bile acid IVD calibratorIVD General
Plasma protein IVD controlPlasma protein IVD controlIVD General
Multiple-type clinical chemistry analyte profile IVD calibratorMultiple-type clinical chemistry analyte profile IVD calibratorIVD General
Multiple-type clinical chemistry analyte profile IVD controlMultiple-type clinical chemistry analyte profile IVD controlIVD General
Ethanol (ETOH) IVD kit enzyme spectrophotometryEthanol (ETOH) IVD kit enzyme spectrophotometryIVD General
C-reactive protein (CRP) IVD kit rapid ICT clinicalC-reactive protein (CRP) IVD kit rapid ICT clinicalIVD General
Ethanol (ETOH) IVD calibrator/controlEthanol (ETOH) IVD calibrator/controlIVD General
Troponin I IVD kit rapid ICT clinicalTroponin I IVD kit rapid ICT clinicalIVD General
Epstein-Barr virus (EBV) heterophile antibody IVD kit rapid ICT clinicalEpstein-Barr virus (EBV) heterophile antibody IVD kit rapid ICT clinicalIVD General
Total immunoglobulin G (IgG total) IVD kit nephelometry/turbidimetryTotal immunoglobulin G (IgG total) IVD kit nephelometry/turbidimetryIVD General
Total immunoglobulin A (IgA total) IVD kit nephelometry/turbidimetryTotal immunoglobulin A (IgA total) IVD kit nephelometry/turbidimetryIVD General
Total immunoglobulin M (IgM total) IVD kit nephelometry/turbidimetryTotal immunoglobulin M (IgM total) IVD kit nephelometry/turbidimetryIVD General
Estradiol (oestradiol) (E2) IVD kit enzyme immunoassay (EIA)Estradiol (oestradiol) (E2) IVD kit enzyme immunoassay (EIA)IVD General
Androstenedione IVD kit enzyme immunoassay (EIA)Androstenedione IVD kit enzyme immunoassay (EIA)IVD General
Total cortisol IVD kit enzyme immunoassay (EIA)Total cortisol IVD kit enzyme immunoassay (EIA)IVD General
Dehydroepiandrosterone sulfate (DHEAS) IVD kit enzyme immunoassay (EIA)Dehydroepiandrosterone sulfate (DHEAS) IVD kit enzyme immunoassay (EIA)IVD General
Progesterone IVD kit enzyme immunoassay (EIA)Progesterone IVD kit enzyme immunoassay (EIA)IVD General
Total testosterone IVD kit enzyme immunoassay (EIA)Total testosterone IVD kit enzyme immunoassay (EIA)IVD General
Free testosterone IVD kit enzyme immunoassay (EIA)Free testosterone IVD kit enzyme immunoassay (EIA)IVD General
Total human chorionic gonadotropin (HCG) IVD kit immunochromatographic test (ICT) rapidTotal human chorionic gonadotropin (HCG) IVD kit immunochromatographic test (ICT) rapidIVD General
Total lactate dehydrogenase (LDH) IVD reagentTotal lactate dehydrogenase (LDH) IVD reagentIVD General
Hepatitis C virus total antibody IVD kit enzyme immunoassay (EIA)Hepatitis C virus total antibody IVD kit enzyme immunoassay (EIA)IVD Annex II List A
Hepatitis B virus surface antigen IVD kit enzyme immunoassay (EIA)Hepatitis B virus surface antigen IVD kit enzyme immunoassay (EIA)IVD Annex II List A
HIV1/HIV2 antibody IVD kit enzyme immunoassay (EIA)HIV1/HIV2 antibody IVD kit enzyme immunoassay (EIA)IVD Annex II List A
HIV1/HIV2 antigen/antibody IVD kit enzyme immunoassay (EIA)HIV1/HIV2 antigen/antibody IVD kit enzyme immunoassay (EIA)IVD Annex II List A
Total cholesterol lipid IVD kit enzyme spectrophotometryTotal cholesterol lipid IVD kit enzyme spectrophotometryIVD General
Multiple Plasmodium species antigen IVD kit rapid ICT clinicalMultiple Plasmodium species antigen IVD kit rapid ICT clinicalIVD General
17-Hydroxyprogesterone IVD kit enzyme immunoassay (EIA)17-Hydroxyprogesterone IVD kit enzyme immunoassay (EIA)IVD General
Homocysteine IVD calibratorHomocysteine IVD calibratorIVD General
Glutamate dehydrogenase IVD kit spectrophotometryGlutamate dehydrogenase IVD kit spectrophotometryIVD General
Free triiodothyronine (FT3) IVD kit enzyme immunoassay (EIA)Free triiodothyronine (FT3) IVD kit enzyme immunoassay (EIA)IVD General
Free thyroxine (FT4) IVD kit enzyme immunoassay (EIA)Free thyroxine (FT4) IVD kit enzyme immunoassay (EIA)IVD General
Multiple form 25-hydroxy Vitamin D IVD kit enzyme immunoassay (EIA)Multiple form 25-hydroxy Vitamin D IVD kit enzyme immunoassay (EIA)IVD General
Transferrin IVD calibratorTransferrin IVD calibratorIVD General
Haptoglobin IVD kit nephelometry/turbidimetryHaptoglobin IVD kit nephelometry/turbidimetryIVD General