Identity
- Trade Name
- OralTox FDA UDI
- Generic Name
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- OralTox 6 Panel - COC/MET/OPI/OXY/PCP/THC FDA UDI
- Model / Reference
- OT80622 FDA UDI
- Description
- OralTox 6 Panel - COC/MET/OPI/OXY/PCP/THC FDA UDI
Identifiers
- Primary DI / UDI-DI
- B313OT806221 FDA UDI
- 510(k) Number
- K181305 FDA UDI
- FDA Product Code
- DJR FDA UDILCM FDA UDIDJG FDA UDIDJC FDA UDIDIO FDA UDI
- GMDN Term
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3620 FDA UDI862.3650 FDA UDI862.3610 FDA UDI862.3250 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
OralTox by Premier Biotech, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Premier Biotech, LLC
Sources (1)
- FDA UDI 490e3f3e-6b74-42e0-a28f-63162aa2c0dd 35 fields · synced May 30, 2026