Dialab_VER_2022NB003IVDD

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: HS20211001 (exp: 2023-01-07)
V02: HS20220401 (exp: 2023-07-01)

Batch verification certificate number

V01: VER 22 003 22 006 rev.1 (Valid)
V02: VER 22 003 22 007 (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 Ag/Ab

 

HIV 1&2 Ag/Ab is an enzyme-linked immunosorbent assay (ELISA) intended for the qualitative detection of antigens and/or antibodies to Human Immunodeficiency Viruses (HIV) type 1 (group M -O) and/or type 2 in human serum or plasma samples. The method is also known as 4th generation ELISA for HIV detection. The kit is intended for screening of blood donors and as an aid in the diagnosis of clinical conditions related to infection with HIV-1 and/or HIV-2 –the etiological agents of the acquired immunodeficiency syndrome (AIDS).

Types/Categories/Models:

Z04380 (96 wells), Z13382 (480 wells)

Classification

Devices in List A