Wantai IVDD0200760122

Certificate verification page

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 020 076 0122
IVDD 020 076 0123

Certificate history

IVDD 020 076 0122 (Initial issue | 30.Mar.2022)
IVDD 020 076 0123 (Initial issue | 30.Mar.2022)

Manufacturer/Holder of certificate

Beijing Wantai Biological Pharmacy Enterprise Co., Ltd
No.31 Kexueyuan Road, Changping District, Beijing 102206, China

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Products within scope

AiDTM anti-HIV 1+2 ELISA


AiDTM anti-HIV 1+2 ELISA is an enzyme-linked immunosorbent assay (ELISA) intended for qualitative detection of antibodies to Human Immunodeficiency Viruses (HIV) type 1 (group M – O) or type 2 in human serum or plasma specimens. The assay can be utilized for screening of blood donors and/or 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).


WI-4396 (96 wells), WI-43480 (480 wells)


List A