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: B20220401 (exp: 2023-07-01)
V02: B20220601 (exp: 2023-09-01)
V03: B20221001 (exp: 2024-01-07)
V04: B20230201 (exp: 2024-05-01)

Batch verification certificate number

V01: VER 20 075 22 001 (Valid)
V02: VER 20 075 22 014 (Valid)
V03: VER 20 075 22 024 (Valid)
V04: VER 20 075 23 035 (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 HBsAg ELISA is an enzyme-linked immunosorbent assay (ELISA) for qualitative detection of HBsAg in human serum or plasma. It is intended for screening of blood donors and for diagnosing of patients related to infection with hepatitis B virus.


WB-1296 (96 wells), WB-12480 (480 wells)


Devices in List A