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Oncomine™ Dx Express Test Plasma cfTNA Control
EUDAMEDClass IVD General (EU MDR)
Ref A50837 (A52168)
Identity
- Trade Name
- Oncomine™ Dx Express Test Plasma cfTNA Control EUDAMED
- Device Name
- Oncomine™ Dx Express Test Plasma cfTNA Control, a part of Ion Torrent™ Oncomine™ Dx Express Test EUDAMED
- Model / Reference
- A50837 (A52168) EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-USMF000023929A5083783 EUDAMED
- Basic UDI-DI
- B-USMF000023929A5083783 EUDAMED
- EMDN Code
- W01060299 TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
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
Oncomine™ Dx Express Test Plasma cfTNA Control by Life Technologies Limited — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-USMF000023929A5083783 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Life Technologies Corporation
- EUDAMED SRN
- US-MF-000023929
- Authorised Representative
- Life Technologies Europe B.V. NL-AR-000021890
Sources (1)
- EUDAMED 720f10ad-624a-49a7-b6e3-151bfe9d61b9 61 fields · synced Jun 18, 2026