Certificate verification page
Directive 98/79/EC on In Vitro Diagnostic Medical Devices
Annex IV section 6 Manufactured batch verification
Verified manufactured batch
V01: B20220401 (exp: 2023-07-01)
Batch verification certificate number
V01: VER 21 061 22 011 (Valid)
Manufacturer/Holder of certificate
MP Biomedicals Asia Pacific Pte. Ltd.
2 Pioneer Place, Singapore 627885 Singapore
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)
Devices in List A