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: HS20211001 (exp: 07 January 2023)
V02: HS20220401 (exp: 01 July 2023)
V03: HS20221001 (exp: 07 January 2024)
V04: HS20230201 (exp: 01 May 2024)
V05: HS20230601 (exp: 14 September 2024)
Batch verification certificate number
V01: VER 22 003 22 006 rev.1 (Valid)
V02: VER 22 003 22 007 (Valid)
V03: VER 22 003 23 031 (Valid)
V04: VER 22 003 23 041 (Valid)
V05: VER 22 003 23 053 (Valid)
Manufacturer/Holder of certificate
DIALAB Produktion und Vertrieb von chemisch-technischen Produkten und Laborinstrumenten Gesellschaft m.b.H
IZ NOE-Sued Hondastrasse Objekt M55, A-2351 Wiener Neudorf, Austria
Other sites
Products within scope
HIV 1&2 Ag/Ab
HIV 1&2 Ag/Ab is an enzyme-linked immunosorbent assay (ELISA) intended for the 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 samples. 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:
Z04380 (96 wells), Z13382 (480 wells)
Classification
Devices in List A