Dialab_IVDD 22 005 0139

Certificate verification page

Certification scheme

Directive 98/79/EC on In Vitro Diagnostic Medical Devices
Annex IV Full quality assurance system and EC design examination

Certificate number

IVDD 22 005 0139
IVDD 22 005 0140

Certificate history

IVDD 22 005 0139 (Initial issue | 24.May.2022)
IVDD 22 005 0140 (Initial issue | 24.May.2022)

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
Effective from


Valid until


Suspension period
Withdrawn on
Validity status
Validity conditions

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)


List A