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: 07 January 2023)
V02: HS20220601 (exp: 07 January 2023)
V03: HS20221001 (exp: 07 January 2024)
V04: HS20230201 (exp: 01 May 2024)
V05: HS20230601 (exp: 14 September 2024)
V06: HS20231101 (exp: 01 February 2025)
V07: HS20240101 (exp: 14 April 2025)
Batch verification certificate number
V01: VER 21 060 22 005 rev.1 (Valid)
V02: VER 21 060 22 020 (Valid)
V03: VER 21 060 23 027 (Valid)
V04: VER 21 060 23 038 (Valid)
V05: VER 21 060 23 050 (Valid)
V06: VER 21 060 23 065 (Valid)
V07: VER 21 060 24 076 (Valid)
Manufacturer/Holder of certificate
MP Biomedicals Asia Pacific Pte. Ltd.
2 Pioneer Place, Singapore 627885 Singapore
Other sites
Products within scope
MP Diagnostics HIV Ag/Ab Combo ELISA 4.0
MP Diagnostics HIV Ag/Ab Combo ELISA 4.0 is an enzyme-linked immunosorbent assay (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:
23040-096 (96 wells), 23040-480 (480 wells)
Classification
Devices in List A
