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 020 075 0120
IVDD 020 075 0121
Certificate history
IVDD 020 075 0120 (Initial issue | 30.Mar.2022)
IVDD 020 075 0121 (Initial issue | 30.Mar.2022)
Manufacturer/Holder of certificate
Beijing Wantai Biological Pharmacy Enterprise Co., Ltd
No.31 Kexueyuan Road, Changping District, Beijing 102206, China
Other sites
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Effective from
30.Mar.2022
Valid until
26.May.2025
Suspension period
–
Withdrawn on
–
Validity status
Valid
Validity conditions
–
Products within scope
AiDTM HBsAg ELISA
AiDTM HBsAg ELISA is an enzyme-linked immunosorbent assay (ELISA) 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.
Types/Categories/Models:
WB-1296 (96 wells), WB-12480 (480 wells)
Classification
List A
