MP Bio_IVDD 21 061 0127

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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 21 061 0127
IVDD 21 061 0128

Certificate history

IVDD 21 061 0127 (Initial issue | 16.May.2022)
IVDD 21 061 0128 (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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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)


List A