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: CS20220401 (exp: 01 July 2023)
V02: CS20220601 (exp: 01 September 2023)
V03: CS20221001 (exp: 07 January 2024)
V04: CS20230201 (exp: 01 May 2024)
V05: CS20230601 (exp: 14 September 2024)
V06: CS20230901 (exp: 14 December 2024)
Batch verification certificate number
V01: VER 20 074 22 004 (Valid)
V02: VER 20 074 22 013 (Valid)
V03: VER 20 074 22 023 (Valid)
V04: VER 20 074 23 034 (Valid)
V05: VER 20 074 23 046 (Valid)
V06: VER 20 074 23 057 (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 anti-HCV ELISA Plus
AiDTM anti-HCV ELISA Plus is an enzyme-linked immunosorbent assay (ELISA) for qualitative detection of antibodies to hepatitis C virus (HCV) in human serum or plasma. It is intended for screening of blood donors and for diagnosing of patients related to infection with hepatitis C virus.
Types/Categories/Models:
WC-31S96 (96 wells), WC-31S480 (480 wells)
Classification
Devices in List A