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: 22205 (exp: 01 July 2023)
V02: 22206 (exp: 01 July 2023)
V03: 23026 (exp: 07 January 2024)
V04: 23142 (exp: 01 May 2024)
V05: 23256 (exp: 14 September 2024)
V06: 24155 (exp: 14 April 2025)
Batch verification certificate number
V01: VER 22 012 22 017 (Valid)
V02: VER 22 012 22 022 (Valid)
V03: VER 22 012 23 033 (Valid)
V04: VER 22 012 23 045 (Valid)
V05: VER 22 012 23 059 (Valid)
V06: VER 22 012 24 077 (Valid)
Manufacturer/Holder of certificate
Adaltis S.r.l.
Via Durini 27, 20122 Milano, Italy
Other sites
Products within scope
EIAgen HBsAg Kit
EIAgen HBsAg Kit is an enzyme-linked immunosorbent assay (ELISA) for qualitative detection of HBsAg in human serum or plasma. It is intended for screening of blood donors and for diagnosing of patients related to infection with hepatitis B virus.
Types/Categories/Models:
071011 (96 tests)
071012 (192 tests)
071015 (480 tests)
Classification
Devices in List A
