UltraGene Assay Combo 4 Screening
by Advanced Biological Laboratories (Abl) S.A. Luxembourg EUDAMED
Ref 150B1000Model UltraGene Assay Combo 4 Screening V2.X (1000 tests) EMDN W0105070304
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-05407007960590 | Date14 Sep 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDD Expiring
Specification
- Device Name
- UltraGene Assay Combo 4 Screening V2.X
- Model / Reference
- UltraGene Assay Combo 4 Screening V2.X (1000 tests), 150B1000
- Primary DI / UDI-DI
- 05407007960590
- Basic UDI-DI
- B-05407007960590
- EMDN Code
- W0105070304 Influenza & para influenza / respiratory syncytial virus (rsv) / sars-cov - multiplex na reagents
- Device Class
- Class IVD General
- Market of Registration
- Luxembourg
Manufacturer details
- EUDAMED SRN
- LU-MF-000003752
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Properties & raw data
Show properties, registry sources and raw records
Other properties (7)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
Sources (1)
- EUDAMED 956582fd-5f49-4060-92ff-655eedec9fba