Dialab_VER_2022NB006IVDD

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: I20220401 (exp: 2023-07-01)

Batch verification certificate number

V01: VER 22 006 22 010 (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

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

Devices in List A