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.
Types/Categories/Models:
23130-096 (96 wells), 23130-480 (480 wells)
Classification
Devices in List A