Identity
- Trade Name
- ORAgene Dx EUDAMEDFDA UDI
- Generic Name
- Specimen stabilization reagent IVD FDA UDI
- Device Name
- ORAgene (Swab-based DNA & Dx Collection Device) EUDAMEDDNA Specimen Collection, Saliva (For assisted collection) FDA UDI
- Model / Reference
- OGD-575 EUDAMEDFDA UDI
- Description
- DNA Specimen Collection, Saliva (For assisted collection) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00627595000224 EUDAMEDFDA UDI
- Basic UDI-DI
- 0627595A0100EF EUDAMED
- 510(k) Number
- K110701 FDA UDI
- FDA Product Code
- OYJ FDA UDI
- EMDN Code
- A1101,W05019002 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 — 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 | 0627595A0100EF | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- DNA Genotek Inc.
- EUDAMED SRN
- CA-MF-000003486
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (2)
- EUDAMED 4b47f7f2-29a4-4696-89cb-e5e460464a23 61 fields · synced Jul 21, 2026
- FDA UDI 4e12c78e-62c4-4ea9-bca3-31b389aa106a 36 fields · synced May 30, 2026