Adaltis_VER_2022NB012IVDD

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: 22205 (exp: 01 July 2023)
V02: 22206 (exp: 01  July 2023)
V03: 23026 (exp: 07 January 2024)

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)

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