Aptima HCV Quant Dx Controls Kit
by Hologic United States EUDAMED
Ref PRD-03508
EMDN W0105080802
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number54200455DIAGAPTHCVAJ | Date10 Jul 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/IVDR Active
EU market availability
Available in 31 countries, as listed in EUDAMED:
- Austria
- Belgium
- Bulgaria
- Croatia
- Cyprus
- Czechia
- Denmark
- Estonia
- Finland
- France
- Germany
- Greece
- Hungary
- Iceland
- Ireland
- Italy
- Latvia
- Liechtenstein
- Lithuania
- Luxembourg
- Malta
- Netherlands
- Northern Ireland
- Norway
- Poland
- Portugal
- Romania
- Slovakia
- Slovenia
- Spain
- Sweden
Certificates
- IVDR 779051 Issued
Technical documentation EU IVDR
- Notified body
- Notified body 2797
- Issued
- 19 May 2026
- Expires
- 18 May 2031
Specification
- Device Name
- Aptima HCV Quant Dx Assay
- Model / Reference
- PRD-03508
- Primary DI / UDI-DI
- 15420045509061
- Basic UDI-DI
- 54200455DIAGAPTHCVAJ
- Unit of Use DI
- 05420045509064
- EMDN Code
- W0105080802 Hepatitis virus controls - inf.imm.
- Device Class
- Class D
- Market of Registration
- Belgium
Manufacturer details
- EUDAMED SRN
- US-MF-000001646
- Authorised representative
- Hologic BV BE-AR-000000127
Other devices from Hologic Inc.
Properties & raw data
Show properties, registry sources and raw records
Other properties (9)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No
Sources (1)
- EUDAMED 15420045509061|54200455DIAGAPTHCVAJ