Wantai_VER_2020NB076IVDD

Certificate verification page

Certification scheme

Directive 98/79/EC on In Vitro Diagnostic Medical Devices
Annex IV section 6 Manufactured batch verification

Verified manufactured batch

V01: I20220401 (exp: 2023-07-01)
V02: I20220601 (exp: 2023-09-01)

Batch verification certificate number

V01: VER 20 076 22 002 (Valid)
V02: VER 20 076 22 015 (Valid)

Manufacturer/Holder of certificate

Beijing Wantai Biological Pharmacy Enterprise Co., Ltd
No.31 Kexueyuan Road, Changping District, Beijing 102206, China

Other sites
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

Devices in List A