Identity
- Trade Name
- OMNIgene Liquefaction Reagent EUDAMEDFDA UDI
- Generic Name
- Nucleic acid extraction/isolation kit IVD FDA UDI
- Device Name
- OMNIgene Liquefaction Reagent EUDAMEDMicrobial DNA Stool Sample Processing, Reagent 800mL FDA UDI
- Model / Reference
- OM-LQR-1600 EUDAMEDFDA UDI
- Description
- Microbial DNA Stool Sample Processing, Reagent 800mL FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00627595000552 EUDAMEDFDA UDI
- Basic UDI-DI
- 0627595I0900JF EUDAMED
- FDA Product Code
- PPM FDA UDI
- EMDN Code
- W01019099 CLINICAL CHEMISTRY REAGENTS - OTHER EUDAMED
- GMDN Term
- Nucleic acid extraction/isolation kit IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 864.4010 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
No
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
No
FDA UDI
Category: Nucleic acid extraction/isolation kit IVD
OMNIgene Liquefaction Reagent by DNA Genotek Inc — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Nucleic acid extraction/isolation kit IVD.
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- MagPure RNA Kit — Chaozhou Hybribio Biochemistry Ltd. · Class A
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 | 0627595I0900JF | 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 f2648ab6-6c8a-4474-8b82-68d65595a417 61 fields · synced Jun 19, 2026
- FDA UDI 61857e73-2c78-4e9b-a9c3-f2a72ea99c36 35 fields · synced May 30, 2026