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NX-Jr Stool NA Kit A
EUDAMEDFDA UDIClass A (EU MDR)
Ref JSN131Model JGD061Ref DSN241Model DGD961
Identity
- Trade Name
- NX-Jr Stool NA Kit A EUDAMEDNX-Duo Stool NA Kit A DSN241 FDA UDI
- Generic Name
- Nucleic acid extraction/isolation kit IVD FDA UDI
- Device Name
- NX-Jr Genomic DNA Kit A EUDAMEDNX-Duo Genomic DNA Kit A EUDAMED
- Model / Reference
- JGD061 EUDAMEDJSN131 EUDAMEDDGD961 EUDAMEDDSN241 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800174503831 EUDAMEDFDA UDI08800174503749 EUDAMED
- Basic UDI-DI
- 88001745-JR-R-5N EUDAMED88001745-DUO-R-6Z EUDAMED
- Direct Marketing DI
- 08800174503831 EUDAMED08800174503749 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
- Germany EUDAMEDSpain 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-Jr Stool NA 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-JR-R-5N | 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 (3)
- EUDAMED dee0f202-6caa-4e98-b333-2691140ada43 61 fields · synced Aug 1, 2026
- EUDAMED 0f9109e1-435a-4088-9ca3-89968210fb6f 61 fields · synced May 17, 2026
- FDA UDI c9ce8daa-6f36-48e6-a20d-9500af921b11 33 fields · synced May 30, 2026