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: CS20230201 (exp: 01 May 2024)
V03: CS20230601 (exp: 14 September 2024)

Batch verification certificate number

V01: VER 21 062 22 012 (Valid)
V02: VER 21 062 23 040 (Valid)
V03: VER 21 062 23 052 (Valid)

Manufacturer/Holder of certificate

MP Biomedicals Asia Pacific Pte. Ltd.

2 Pioneer Place, Singapore 627885 Singapore

Other sites
Products within scope

MP Diagnostics HCV ELISA 4.0

The MP Diagnostics HCV ELISA 4.0 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.


23130-096 (96 wells), 23130-480 (480 wells)


Devices in List A