Wantai IVDD0200770112

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 020 077 0112 rev.1
IVDD 020 077 0113 rev.1

Certificate history

IVDD 020 077 0112 rev.1 (Revision | 25.May.2022 – administrative change only)
IVDD 020 077 0113 rev.1 (Revision | 25.May.2022 – administrative change only)

IVDD 020 077 0112 (Initial issue | 19.Jan.2022 – 24.May.2022)
IVDD 020 077 0113 (Initial issue | 19.Jan.2022 – 24.May.2022)

Manufacturer/Holder of certificate

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

Other sites
Effective from



Valid until


Suspension period
Withdrawn on
Validity status
Validity conditions

Products within scope

AiDTM HIV 1+2 Ag/Ab ELISA Plus


Diagnostic Kit for Antibody and Antigen to Human Immunodeficiency Virus (ELISA) intended for 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 specimens. 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).



WI-44S96 (96 wells)
WI-44S480 (480 wells)


List A