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.


Z13370 (96 wells), Z13500 (480 wells)


Devices in List A