Identity
- Trade Name
- Oragene Dx FDA UDI
- Generic Name
- Specimen stabilization reagent IVD FDA UDI
- Device Name
- DNA Specimen collection, Saliva FDA UDI
- Model / Reference
- OXD-500 FDA UDI
- Description
- DNA Specimen collection, Saliva FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00627595000279 FDA UDI
- 510(k) Number
- K110701 FDA UDI
- FDA Product Code
- OYJ FDA UDI
- GMDN Term
- Specimen stabilization reagent IVD FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1675 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Oragene Dx by DNA Genotek Inc — Class II — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- DNA Genotek Inc
Sources (2)
- FDA UDI 8ce640e8-be06-4a71-b42d-2875647096f8 37 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 2, 2026