Certificate verification page
Directive 98/79/EC on In Vitro Diagnostic Medical Devices
Annex IV Full quality assurance system and EC design examination
IVDD 21 062 0129
IVDD 21 062 0130
IVDD 21 062 0129 (Initial issue | 16.May.2022)
IVDD 21 062 0130 (Initial issue | 16.May.2022)
Manufacturer/Holder of certificate
MP Biomedicals Asia Pacific Pte. Ltd.
2 Pioneer Place, Singapore 627885, Singapore
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)