Certificate verification page
Directive 98/79/EC on In Vitro Diagnostic Medical Devices
Annex IV Full quality assurance system and EC design examination
IVDD 21 060 0125
IVDD 21 060 0126
IVDD 21 060 0125 (Initial issue | 12.April.2022)
IVDD 21 060 0126 (Initial issue | 12.April.2022)
Manufacturer/Holder of certificate
MP Biomedicals Asia Pacific Pte. Ltd.
2 Pioneer Place, Singapore 627885, Singapore
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).
23040-096 (96 wells), 23040-480 (480 wells)