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 020 076 0122
IVDD 020 076 0123
Certificate history
IVDD 020 076 0122 (Initial issue | 30.Mar.2022)
IVDD 020 076 0123 (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Withdrawn on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 anti-HIV 1+2 ELISA
AiDTM anti-HIV 1+2 ELISA is an enzyme-linked immunosorbent assay (ELISA) intended for qualitative detection of antibodies to Human Immunodeficiency Viruses (HIV) type 1 (group M – O) or type 2 in human serum or plasma specimens. The assay can be utilized for screening of blood donors and/or as an aid in the diagnosis of clinical conditions related to infection with HIV-1 and /or HIV-2 – the etiological agents of the acquired immunodeficiency syndrome (AIDS).
Types/Categories/Models:
WI-4396 (96 wells), WI-43480 (480 wells)
Classification
List A