Identity
- Trade Name
- NX-Duo cfDNA Kit A DCF244 FDA UDI
- Generic Name
- Nucleic acid extraction/isolation kit IVD FDA UDI
- Device Name
- NX-Duo Genomic DNA Kit A EUDAMED
- Model / Reference
- DGD961 EUDAMEDDCF244 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800174502940 EUDAMEDFDA UDI
- Basic UDI-DI
- 88001745-DUO-R-6Z EUDAMED
- Direct Marketing DI
- 08800174502940 EUDAMED
- FDA Product Code
- JJH FDA UDI
- EMDN Code
- W0105040599 VIROLOGY - NA REAGENTS - OTHER EUDAMED
- GMDN Term
- Nucleic acid extraction/isolation kit IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 862.2310 FDA UDI
- Market of Registration
- Spain EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Prescription Use
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
NX-Duo Genomic DNA Kit A by Genolution. Inc. — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 88001745-DUO-R-6Z | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Genolution Inc.
- EUDAMED SRN
- KR-MF-000010391
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (2)
- EUDAMED e8156cd0-0371-47e6-a1a4-e0af444d1568 61 fields · synced Jul 17, 2026
- FDA UDI 6e822e37-9df0-40d7-b656-31121538fb24 33 fields · synced May 29, 2026