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: 01 July 2023)
V02: I20220601 (exp: 01 September 2023)
V03: I20222101 (exp: 07 January 2024)
V04: I20230201 (exp: 01 May 2024)
V05: I20230601 (exp: 14 September 2024)
V06: I20231101 (exp: 01 February 2025)
Batch verification certificate number
V01: VER 20 076 22 002 (Valid)
V02: VER 20 076 22 015 (Valid)
V03: VER 20 076 22 025 (Valid)
V04: VER 20 076 23 036 (Valid)
V05: VER 20 076 23 048 (Valid)
V06: VER 20 076 23 063 (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