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)

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)

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.


23470-096 (96 wells), 23470-480 (480 wells)


Devices in List A