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Oncomine™ Solid Tumour Fusion Transcript Kit (Part 2 of 2)
EUDAMEDClass IVD General (EU MDR)
Ref A2676202 (A26762)
Identity
- Trade Name
- Oncomine™ Solid Tumour Fusion Transcript Kit (Part 2 of 2) EUDAMED
- Device Name
- Oncomine™ Solid Tumour Fusion Transcript Kit (Part 2 of 2), a part of Oncomine™ Solid Tumour Kits EUDAMED
- Model / Reference
- A2676202 (A26762) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10190302006880 EUDAMED
- Basic UDI-DI
- B-10190302006880 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
No
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™ Solid Tumour Fusion Transcript Kit (Part 2 of 2) by Life Technologies Limited — Class IVD General — IVDD — listed in EUDAMED
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-10190302006880 | 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 b1b2a07e-940a-485a-b2a1-aa2a8e5941f6 61 fields · synced Jul 13, 2026