Certificate verification page
Certification scheme
Directive 98/79/EC on In Vitro Diagnostic Medical Devices
Annex IV Full quality assurance system and EC design examination
Certificate number
IVDD 22 012 0146
IVDD 22 012 0147
Certificate history
IVDD 22 012 0146 (Initial issue | 25.May.2022)
IVDD 22 012 0147 (Initial issue | 25.May.2022)
Manufacturer/Holder of certificate
Adaltis S.r.l.
Via Durini 27, 20122 Milano, Italy
Other sites
Via Luigi Einaudi 7, 00012 Guidonia Montecelio (RM), Italy
Effective from
25.May.2022
Valid until
26.May.2025
Suspension period
–
Withdrawn on
–
Validity status
Valid
Validity conditions
–
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 (132 tests)
071015 (480 tests)
Classification
Device in List A