Dialab_IVDD 22 004 0137

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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

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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.


Z12360 (96 wells)


List A