Dialab_IVDD 22 003 0135

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Certification scheme

Directive 98/79/EC on In Vitro Diagnostic Medical Devices
Annex IV Full quality assurance system and EC design examination

Certificate number

IVDD 22 003 0135
IVDD 22 003 0136

Certificate history

IVDD 22 003 0135 (Initial issue | 24.May.2022)
IVDD 22 003 0136 (Initial issue | 24.May.2022)

Manufacturer/Holder of certificate

DIALAB Produktion und Vertrieb von chemisch-technischen Produkten und Laborinstrumenten Gesellschaft m.b.H
IZ NOE-Sued Hondastrasse Objekt M55, A-2351 Wiener Neudorf, Austria

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Products within scope

HIV 1&2 Ag/Ab


HIV 1&2 Ag/Ab is an enzyme-linked immunosorbent assay (ELISA) intended for the qualitative detection of antigens and/or antibodies to Human Immunodeficiency Viruses (HIV) type 1 (group M -O) and/or type 2 in human serum or plasma samples. The method is also known as 4th generation ELISA for HIV detection. The kit is intended for screening of blood donors and as an aid in the diagnosis of clinical conditions related to infection with HIV-1 and/or HIV-2 –the etiological agents of the acquired immunodeficiency syndrome (AIDS).


Z04380 (96 wells)
Z13382 (480 wells)


List A