MP Bio_IVDD 21 061 0129

Certificate verification page

Certification scheme

Directive 98/79/EC on In Vitro Diagnostic Medical Devices
Annex IV Full quality assurance system and EC design examination

Certificate number

IVDD 21 062 0129
IVDD 21 062 0130

Certificate history

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

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Suspension period
Withdrawn on
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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)


List A