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: 2023-07-01)
V02: CS20220601(exp: 2023-09-01)

Batch verification certificate number

V01: VER 22 005 22 009 (Valid)
V02: VER 22 005 22 019 (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