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Oncomine™ Dx Target Test (DNA and RNA Panel)
EUDAMEDFDA UDIClass IVD General (EU MDR)
Ref A32441 (A49756)Ref A65534 （A65538)
Identity
- Trade Name
- Oncomine™ Dx Target Test (DNA and RNA Panel) EUDAMEDOncomine™ Dx Target Test FDA UDI
- Generic Name
- Multiple tissue-associated protein/tumour marker IVD, reagent FDA UDI
- Device Name
- Oncomine™ Dx Target Test (DNA and RNA Panel), a part of Oncomine™ Dx Target Test EUDAMEDOncomine™ Dx Target Test EUDAMED
- Model / Reference
- A32441 (A49756) EUDAMEDA65534 （A65538) EUDAMEDA32441 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10190302015103 EUDAMEDFDA UDI10190302019620 EUDAMED
- Basic UDI-DI
- B-10190302015103 EUDAMED0190302A49756TV 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
- Multiple tissue-associated protein/tumour marker IVD, reagent FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass C 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
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
EUDAMEDEUDAMED
Surgical Instrument
No
EUDAMED
New Device
Yes
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 Test (DNA and RNA Panel) by Life Technologies Limited — Class IVD General — IVDR, IVDD, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
European Union Active
CE/IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | B-10190302015103 | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-10190302015103 | 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 (3)
- EUDAMED 843d4912-9fad-43ce-9f31-38d8c6090796 61 fields · synced Jul 19, 2026
- EUDAMED d54a67f6-549e-44d5-9860-5169670d531d 61 fields · synced May 18, 2026
- FDA UDI dbb11fce-bd4d-4b46-9312-2b20e91e9676 33 fields · synced May 30, 2026