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NX Genomic DNA Kit A
EUDAMEDFDA UDIClass A (EU MDR)
Ref CVD241Model NGD961Ref CVR241Ref CFF291Ref CVR291Ref CFF241Ref NUE962
Identity
- Trade Name
- NX Universal DNA Kit B NUE962 FDA UDI
- Generic Name
- Nucleic acid extraction/isolation kit IVD FDA UDI
- Device Name
- NX Genomic DNA Kit A EUDAMED
- Model / Reference
- NGD961 EUDAMEDCVD241 EUDAMEDCVR241 EUDAMEDCFF291 EUDAMEDCVR291 EUDAMEDCFF241 EUDAMEDNUE962 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800174502384 EUDAMED08800174502407 EUDAMED08800174502490 EUDAMED08800174502414 EUDAMED08800174502513 EUDAMED08800174503015 EUDAMEDFDA UDI
- Basic UDI-DI
- 88001745-48N-R-NY EUDAMED
- Direct Marketing DI
- 08800174502384 EUDAMED08800174502407 EUDAMED08800174502490 EUDAMED08800174502414 EUDAMED08800174502513 EUDAMED08800174503015 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 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 | 88001745-48N-R-NY | 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 (7)
- EUDAMED da4fe1f8-9904-4f4a-a7f0-c30b07409598 61 fields · synced Aug 3, 2026
- EUDAMED 5d6d8996-2832-4892-a7c3-20c61ed55630 61 fields · synced May 16, 2026
- EUDAMED af7f551c-880b-4273-8e22-b4fff9605b1f 61 fields · synced May 17, 2026
- EUDAMED 8e94029e-24c6-4726-b377-4126b79741a6 61 fields · synced May 18, 2026
- EUDAMED fbc8c295-99be-4099-a8d7-9dcedb7f8b63 61 fields · synced May 18, 2026
- EUDAMED be941772-e247-4011-b18b-7f00272cdd4d 61 fields · synced May 19, 2026
- FDA UDI 94070ac1-2cdb-4310-9655-1be4063616ff 33 fields · synced May 30, 2026