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: 01 July 2023)
V02: B20220601 (exp: 01 September 2023)
V03: B20221001 (exp: 07 July 2024)
V04: B20230201 (exp: 01 May 2024)
V05: B20230601 (exp: 14 September 2024)
V06: B20230901 (exp: 14 December 2024)
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)
V05: VER 20 075 23 047 (Valid)
V06: VER 20 075 23 058 (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
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.
Types/Categories/Models:
WB-1296 (96 wells), WB-12480 (480 wells)
Classification
Devices in List A