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: 07 January 2023)
V02: B20220601 (exp: 07 January 2023)
V03: B20221001 (exp: 07 January 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 21 061 22 011 (Valid)
V02: VER 21 061 22 021 (Valid)
V03: VER 21 061 23 028 (Valid)
V04: VER 21 061 23 039 (Valid)
V05: VER 21 061 23 051 (Valid)
V06: VER 21 061 23 060 (Valid)
Manufacturer/Holder of certificate
MP Biomedicals Asia Pacific Pte. Ltd.
2 Pioneer Place, Singapore 627885 Singapore
Other sites
Products within scope
MP Diagnostics HBsAg ELISA 4.1
The MP Diagnostics HBsAg ELISA 4.1 is an enzyme-linked immunosorbent assay (ELISA) intended 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:
23470-096 (96 wells), 23470-480 (480 wells)
Classification
Devices in List A