Wantai IVDD0200750120

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
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Withdrawn on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

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