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Genexus™ Dx Nucleic Acid Quantitation
EUDAMEDClass A (EU MDR)
Ref A51078 (A52170, A52171)
Identity
- Trade Name
- Genexus™ Dx Nucleic Acid Quantitation EUDAMED
- Device Name
- Genexus™ Dx Nucleic Acid Quantitation, a part of Ion Torrent™ Genexus™ Dx FFPE DNA/RNA and cfTNA Purification Kit EUDAMED
- Model / Reference
- A51078 (A52170, A52171) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10190302017626 EUDAMED
- Basic UDI-DI
- 0190302A51078RP EUDAMED
- EMDN Code
- W010699 GENETIC TESTS - OTHER EUDAMED
Classification
- Device Class
- Class A 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
New Device
No
EUDAMED
Genexus™ Dx Nucleic Acid Quantitation by Life Technologies Limited — Class A — 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 | 0190302A51078RP | Class A | 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 7feff0f4-451d-4483-8922-0974611bfade 61 fields · synced Jun 19, 2026
- EUDAMED 7feff0f4-451d-4483-8922-0974611bfade-1 61 fields · synced Jun 10, 2026