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 22 006 0141
IVDD 22 006 0142
Certificate history
IVDD 22 006 0141 (Initial issue | 24.May.2022)
IVDD 22 006 0142 (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Withdrawn on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
HIV 1&2 Ab, cut-off
HIV 1&2 Ab, cut-off is an enzyme-linked immunosorbent assay (ELISA) for the qualitative detection of antibodies against Human Immunodeficiency Viruses (HIV) type 1 (group M-O) and/or type 2 in human serum or plasma samples. It is intended for the screening of blood donors and for diagnosing of patients related to infection with HIV-1 and/or HIV-2 –the etiological agents of the acquired immunodeficiency syndrome (AIDS).
Types/Categories/Models:
Z01375 (96 wells)
Z03502 (480 wells)
Classification
List A
