Dialab_VER_2022NB004IVDD

Certificate verification page

bqs. s.r.o.
Notified body 2854 | SKTC 180 | Accredited certification body
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)
V06:
B20230901 (exp: 14 December 2024)
V07: B20240101 (exp: 14 April 2025)

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)
V06: VER 22 004 23 061 (Valid)
V07: VER 22 004 24 073 (Valid)

Manufacturer/Holder of certificate
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