AlloSeq Tx
by CareDx AB EUDAMED
Active
Ref 404.112-96Model AlloSeq Tx
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number73400355ASTXLU | Date30 Mar 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- AlloSeq Tx
- Model / Reference
- AlloSeq Tx, 404.112-96
- Primary DI / UDI-DI
- 07340035526148
- Basic UDI-DI
- 73400355ASTXLU
- Direct Marketing DI
- 07340035526148
- EMDN Code
- W01030403 Hla antigen typing
- Device Class
- Class C
- Market of Registration
- Sweden
Manufacturer details
- EUDAMED SRN
- SE-MF-000040995
Other devices from CareDx AB
Properties
Other properties (8)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No