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Oncomine™ Dx Target DNA Control v2.0 Kit
EUDAMEDClass C (EU MDR)
Ref A65535 (A65538)
Identity
- Trade Name
- Oncomine™ Dx Target DNA Control v2.0 Kit EUDAMED
- Device Name
- Oncomine™ Dx Target Test EUDAMED
- Model / Reference
- A65535 (A65538) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10190302019637 EUDAMED
- Basic UDI-DI
- 0190302A49756TV EUDAMED
- EMDN Code
- W01060299 TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER EUDAMED
Classification
- Device Class
- Class C 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
Yes
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
Yes
EUDAMED
Oncomine™ Dx Target DNA Control v2.0 Kit by Life Technologies Limited — Class C — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 0190302A49756TV | Class C | 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 cdb891f0-4ee4-46df-b1ba-c0c1d2630596 61 fields · synced Jul 18, 2026