Identity
- Trade Name
- UCP Home FDA UDI
- Generic Name
- Barbiturate IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- UCP Home Drug Screening Test Strips Barbiturates Test Strip FDA UDI
- Model / Reference
- U-BAR-101 FDA UDI
- Description
- UCP Home Drug Screening Test Strips Barbiturates Test Strip FDA UDI
Identifiers
- Catalog Number
- U-BAR-101 FDA UDI
- Primary DI / UDI-DI
- 10817038021252 FDA UDI
- 510(k) Number
- K050540 FDA UDI
- FDA Product Code
- DIS FDA UDI
- GMDN Term
- Barbiturate IVD, kit, rapid ICT, clinical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3150 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: Barbiturate IVD, kit, rapid ICT, clinical
UCP Home by Ucp Biosciences, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Barbiturate IVD, kit, rapid ICT, clinical.
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Cleared under the same submission
K050540 also covers:
- UCP Home Drug Screening Test Cards — MEDICAL DISTRIBUTION GROUP INC
- UCP Compact Drug Test Cassette — UCP BIOSCIENCES, INC.
- UCP Home — UCP BIOSCIENCES, INC.
- UCP Home — UCP BIOSCIENCES, INC.
- UCP Home — UCP BIOSCIENCES, INC.
- UCP Home Drug Screening Test Cards — UCP BIOSCIENCES, INC.
- UCP Home Drug Screening Test Cards — UCP BIOSCIENCES, INC.
- UCP Home Drug Screening Test Cards — UCP BIOSCIENCES, INC.
- UCP Home Drug Screening Test Cards — UCP BIOSCIENCES, INC.
- UCP Home Drug Screening Test Cards — UCP BIOSCIENCES, INC.
- UCP Home Drug Screening Test Cards — UCP BIOSCIENCES, INC.
- UCP Home Drug Screening Test Cards — UCP BIOSCIENCES, INC.
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 ece22855-e61a-4271-a974-b21f28e9f1d3 36 fields · synced Jun 8, 2026