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Oncomine™ Dx Target RNA Control Kit
EUDAMEDFDA UDIClass IVD General (EU MDR)
Ref A32443 (A49756)
Identity
- Trade Name
- Oncomine™ Dx Target RNA Control Kit EUDAMEDFDA UDI
- Generic Name
- Nucleic acid hybridization detection IVD, control FDA UDI
- Device Name
- Oncomine™ Dx Target RNA Control Kit, a part of Oncomine™ Dx Target Test EUDAMED
- Model / Reference
- A32443 (A49756) EUDAMEDA32443 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10190302006064 EUDAMEDFDA UDI
- Basic UDI-DI
- B-10190302006064 EUDAMED
- PMA Number
- P160045 FDA UDI
- FDA Product Code
- PQP FDA UDI
- EMDN Code
- W01060299 TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER EUDAMED
- GMDN Term
- Nucleic acid hybridization detection IVD, control FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass III FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Oncomine™ Dx Target RNA Control Kit by Life Technologies Limited — Class IVD General — IVDD, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-10190302006064 | Class IVD General | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IVD General | Pending data |
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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 0af8f550-5119-4af2-a8db-0a94b00c0cdc 61 fields · synced Jun 18, 2026
- FDA UDI 41235f58-0839-4e49-82d1-7b3fdbaee26d 33 fields · synced May 30, 2026