Identity
- Trade Name
- ORAgene Dx EUDAMEDFDA UDI
- Generic Name
- Specimen stabilization reagent IVD FDA UDI
- Device Name
- ORAgene EUDAMEDDNA Specimen Collection, Saliva FDA UDI
- Model / Reference
- OGD-600 EUDAMEDFDA UDI
- Description
- DNA Specimen Collection, Saliva FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00627595000248 EUDAMEDFDA UDI
- Basic UDI-DI
- 0627595E0500GF EUDAMED
- FDA Product Code
- OYJ FDA UDI
- EMDN Code
- W05019002 SALIVA COLLECTION DEVICES EUDAMED
- GMDN Term
- Specimen stabilization reagent IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass II FDA UDI
- Regulation Number
- 862.1675 FDA UDI
- Market of Registration
- Belgium 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
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
Yes
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 A — FDA_510K, IVDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K152556 | Class A | Active |
| EUDAMED | European Union | CE/IVDR | 0627595E0500GF | Class A | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- DNA Genotek Inc.
- EUDAMED SRN
- CA-MF-000003486
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (3)
- EUDAMED d472cc13-d4c0-4740-8df5-a54f8ba0892e 61 fields · synced Jul 14, 2026
- FDA UDI 85d02c04-e38d-40f3-b36e-802c1ee338ca 36 fields · synced May 30, 2026
- FDA 510(k) K152556 1 fields · synced May 18, 2026