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 22 004 0137
IVDD 22 004 0138
Certificate history
IVDD 22 004 0137 (Initial issue | 24.May.2022)
IVDD 22 004 0138 (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
24.May.2022
Valid until
26.May.2025
Suspension period
–
Withdrawn on
–
Validity status
Valid
Validity conditions
–
Products within scope
HBsAg Sensitive ELISA
HBsAg Sensitive ELISA is an enzyme-linked immunosorbent assay (ELISA)for the qualitative detection of Hepatitis B surface antigen (HBsAg) in human serum or plasma. It is intended for the screening of blood donors and for the diagnosis of patients related to infection with Hepatitis B virus.
Types/Categories/Models:
Z12360 (96 wells)
Classification
List A
