Identity
- Trade Name
- U-Cup TM Drug Test Screen FDA UDI
- Generic Name
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- U-Cup TM Drug Test Screen 6 Panel Drug Test Cup THC/BZO/OXY/OPI/COC/MET FDA UDI
- Model / Reference
- U-CUP-564 FDA UDI
- Description
- U-Cup TM Drug Test Screen 6 Panel Drug Test Cup THC/BZO/OXY/OPI/COC/MET FDA UDI
Identifiers
- Catalog Number
- U-CUP-564 FDA UDI
- Primary DI / UDI-DI
- 10817038021948 FDA UDI
- FDA Product Code
- DJG FDA UDIDJC FDA UDILDJ FDA UDIDIO FDA UDIJXM FDA UDI
- GMDN Term
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3650 FDA UDI862.3610 FDA UDI862.3870 FDA UDI862.3250 FDA UDI862.3170 FDA UDI
- Commercial Distribution
- 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
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
Category: Multiple drugs of abuse IVD, kit, rapid ICT, clinical
U-Cup TM Drug Test Screen by Ucp Biosciences, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Ucp Biosciences, Inc.
Sources (1)
- FDA UDI be737dc7-4129-4c12-b2be-90f88ba3fd98 35 fields · synced May 30, 2026