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AlloSeq Tx
EUDAMEDClass C (EU MDR)
Ref 404.092-96Model AlloSeq Tx 17
by CareDx AB
Identity
- Device Name
- AlloSeq Tx EUDAMED
- Model / Reference
- AlloSeq Tx 17 EUDAMED404.092-96 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07340035526056 EUDAMED
- Basic UDI-DI
- 73400355ASTXLU EUDAMED
- Direct Marketing DI
- 07340035526056 EUDAMED
- EMDN Code
- W01030403 HLA ANTIGEN TYPING EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Sweden EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
Yes
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Category: HLA class I & II antigen tissue typing IVD, kit, multiplex
AlloSeq Tx by CareDx AB — Class C — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as HLA class I & II antigen tissue typing IVD, kit, multiplex.
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 73400355ASTXLU | Class C | Active |
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Manufacturer
- Manufacturer
- CareDx AB
- EUDAMED SRN
- SE-MF-000040995
Sources (1)
- EUDAMED ec37cd98-0652-423d-8270-e02219d0656d 61 fields · synced Jun 19, 2026