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: CS20220401 (exp: 01 July 2023)
V02: CS20220601 (exp: 01 September 2023)
V03: CS20221001 (exp: 07 January 2024)
V04: CS20230201 (exp: 01 May 2024)
V05: CS20230601 (exp: 14 September 2024)
Batch verification certificate number
V01: VER 22 005 22 009 (Valid)
V02: VER 22 005 22 019 (Valid)
V03: VER 22 005 23 029 (Valid)
V04: VER 22 005 23 043 (Valid)
V05: VER 22 005 23 055 (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
HCV Ab Sensitive
HCV Ab Sensitive is an enzyme-linked immunosorbent assay (ELISA) for the qualitative detection of antibodies against Hepatitis C Virus (HCV) in human serum or plasma. It is intended for the screening of blood donors and for diagnosing of patients related to infection with Hepatitis C virus.
Types/Categories/Models:
Z13370 (96 wells), Z13500 (480 wells)
Classification
Devices in List A