Identity
- Trade Name
- OMNIgene ORAL EUDAMEDFDA UDI
- Generic Name
- Oral/respiratory tract specimen container IVD, additive/medium FDA UDI
- Device Name
- OMNIgene ORAL EUDAMEDNucleic Acids Specimen Collection and Stabilization, Saliva. FDA UDI
- Model / Reference
- OME-505.005 EUDAMEDOME-505 EUDAMEDFDA UDI
- Description
- Nucleic Acids Specimen Collection and Stabilization, Saliva. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00627595000798 EUDAMED00627595000675 EUDAMEDFDA UDI
- Basic UDI-DI
- 0627595F0600GX EUDAMED
- FDA Product Code
- LIO FDA UDI
- EMDN Code
- W05019002 SALIVA COLLECTION DEVICES EUDAMED
- GMDN Term
- Oral/respiratory tract specimen container IVD, additive/medium FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 866.2900 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
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
No
FDA UDI
OMNIgene ORAL 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 | 0627595F0600GX | 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 (3)
- EUDAMED b78c3d36-23c6-4aab-9644-c49086adfd86 61 fields · synced Jul 29, 2026
- EUDAMED eafb7577-275b-4417-b4c8-3bde8a0b8bb6 61 fields · synced May 18, 2026
- FDA UDI 0bf02061-1ee4-4641-8f3c-1a496f1b78a8 35 fields · synced May 30, 2026