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
Other sites
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.
Types/Categories/Models:
Z12360 (96 wells)
Classification
Devices in List A