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: I20221001 (exp: 07 January 2024)
V03: I20230201 (exp: 01 May 2024)
V04: I20230601 (exp: 14 September 2024)
Batch verification certificate number
V01: VER 22 006 22 010 (Valid)
V02: VER 22 006 23 030 (Valid)
V03: VER 22 006 23 044 (Valid)
V04: VER 22 006 23 056 (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 Ab, cut-off
HIV 1&2 Ab, cut-off is an enzyme-linked immunosorbent assay (ELISA) for the qualitative detection of antibodies against Human Immunodeficiency Viruses (HIV) type 1 (group M-O) and/or type 2 in human serum or plasma samples. It is intended for the screening of blood donors and for diagnosing of patients related to infection with HIV-1 and/or HIV-2 –the etiological agents of the acquired immunodeficiency syndrome (AIDS).
Types/Categories/Models:
Z01375 (96 wells), Z03502 (480 wells)
Classification
Devices in List A