Certificate verification page
Certification scheme
Directive 98/79/EC on In Vitro Diagnostic Medical Devices
Annex IV section 6 Manufactured batch verification
Verified manufactured batch
V01: HS20220401 (exp: 01 July 2023)
V02: HS20220601 (exp: 01 September 2023)
V03: HS20221001 (exp: 07 January 2024)
V04: HS20230201 (exp: 01 May 2024)
V05: HS20230601 (exp: 14 September 2024)
V06: HS20231101 (exp: 01 February 2025)
Batch verification certificate number
V01: VER 20 077 22 003 (Valid)
V02: VER 20 077 22 016 (Valid)
V03: VER 20 077 22 026 (Valid)
V04: VER 20 077 23 037 (Valid)
V05: VER 20 077 23 049 (Valid)
V06: VER 20 077 23 064 (Valid)
Manufacturer/Holder of certificate
Beijing Wantai Biological Pharmacy Enterprise Co., Ltd
No.31 Kexueyuan Road, Changping District, Beijing 102206, China
Other sites
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).
Types/Categories/Models:
WI-44S96 (96 wells)
WI-44S480 (480 wells)
Classification
Devices in List A