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: B20220401 (exp: 01 July 2023)
V02: B20220601 (exp: 01 September 2023)
V03: B20221001 (exp: 07 January 2024)
V04: B20230201 (exp: 01 May 2024)
V05: B20230601 (exp: 14 September 2024)

Batch verification certificate number

V01: VER 22 004 22 008 (Valid)
V02: VER 22 004 22 018 (Valid)
V03: VER 22 004 23 032 (Valid)
V04: VER 22 004 23 042 (Valid)
V05: VER 22 004 23 054 (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

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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)


Devices in List A