Wantai_VER_2020NB077IVDD

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: HS20220401 (exp: 2023-07-01)

Batch verification certificate number

V01: VER 20 077 22 003 (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 HIV 1+2 Ag/Ab ELISA Plus

 

Diagnostic Kit for Antibody and Antigen to Human Immunodeficiency Virus (ELISA) intended for qualitative detection of antigens and/or antibodies to Human Immunodeficiency Viruses (HIV) type 1 (group M -O) and/or type 2 in human serum or plasma specimens. The method is also known as 4th generation ELISA for HIV detection. The kit is intended for screening of blood donors and 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-44S96 (96 wells)
WI-44S480 (480 wells)

Classification

Devices in List A