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Oncomine™ Dx Target Test User Guides and Assay Definition File
EUDAMEDClass IVD General (EU MDR)
Ref A52639 (A49756)Ref A54452 (A65538)Model A54452
Identity
- Trade Name
- Oncomine™ Dx Target Test User Guides and Assay Definition File EUDAMED
- Device Name
- Oncomine™ Dx Target Test User Guides and Assay Definition File, a part of Oncomine™ Dx Target Test EUDAMEDOncomine™ Dx Target Test User Guides and Assay Definition File EUDAMED
- Model / Reference
- A52639 (A49756) EUDAMEDA54452 EUDAMEDA54452 (A65538) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10190302017763 EUDAMED10190302018333 EUDAMED
- Basic UDI-DI
- B-10190302017763 EUDAMED0190302A54452SE EUDAMED
- EMDN Code
- W02050182 NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - SOFTWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class IVD General EUDAMEDClass C EUDAMED
- Special Device Type
- -1202 EUDAMEDSoftware EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMEDEUDAMED
Surgical Instrument
No
EUDAMED
New Device
Yes
EUDAMED
Oncomine™ Dx Target Test User Guides and Assay Definition File by Life Technologies Limited — Class IVD General — IVDR, IVDD — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | B-10190302017763 | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-10190302017763 | 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 (2)
- EUDAMED 008914be-48fe-419f-89ca-93a941ae2b7f 61 fields · synced Jul 29, 2026
- EUDAMED 625b3dd8-1a3a-4d7c-9d3e-03b8dd288266 61 fields · synced May 18, 2026