Identity
- Trade Name
- UCP Home Drug Screening Test Cards FDA UDI
- Generic Name
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- 6 Panel Drug Test Card COC/AMP/mAMP/THC/OPI/BZO FDA UDI
- Model / Reference
- U-DOA-264 FDA UDI
- Description
- 6 Panel Drug Test Card COC/AMP/mAMP/THC/OPI/BZO FDA UDI
Identifiers
- Catalog Number
- U-DOA-264 FDA UDI
- Primary DI / UDI-DI
- 10817038020484 FDA UDI
- FDA Product Code
- JXM FDA UDIDJG FDA UDILDJ FDA UDIDJC FDA UDIDKZ 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
- 862.3170 FDA UDI862.3650 FDA UDI862.3870 FDA UDI862.3610 FDA UDI862.3100 FDA UDI862.3250 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
UCP Home Drug Screening Test Cards by Ucp Biosciences, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple drugs of abuse IVD, kit, rapid ICT, clinical.
- OneScreen — AMERICAN SCREENING, L.L.C. · U
- Identify® Diagnostics Drug Test Cards — MEDICAL DISTRIBUTION GROUP INC · Class II
- Healgen (Private Label) - 264 — Confirm Biosciences LLC · Class II
- STATDIP® — MICRO DISTRIBUTING, L.C · Class II
- STATDIP® — MICRO DISTRIBUTING, L.C · Class II
- Precision Plus — AMERICAN SCREENING, L.L.C. · Class II
- DrugCheck — Express Diagnostic Int'l, Inc. · Class II
- QuickProfile™ THC Test Strip — LumiQuick Diagnostics, Inc. · Class II
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 — 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.
K130463 also covers:
- Identify Diagnostics Drug Test Cups — MEDICAL DISTRIBUTION GROUP INC
- Identify Diagnostics Drug Test Cups — MEDICAL DISTRIBUTION GROUP INC
- Identify Diagnostics Drug Test Cups — MEDICAL DISTRIBUTION GROUP INC
- Identify Home Drug Testing Device Test Cups — MEDICAL DISTRIBUTION GROUP INC
- Identify Home Drug Testing Device Test Cups — MEDICAL DISTRIBUTION GROUP INC
- Identify Home Drug Testing Device Test Cups — MEDICAL DISTRIBUTION GROUP INC
- Identify Home Drug Testing Device Test Cups — MEDICAL DISTRIBUTION GROUP INC
- Identify Home Drug Testing Device Test Cups — MEDICAL DISTRIBUTION GROUP INC
- Identify Home Drug Testing Device Test Cups — MEDICAL DISTRIBUTION GROUP INC
- Identify Home Drug Testing Device Test Cups — MEDICAL DISTRIBUTION GROUP INC
- Identify Home Drug Testing Device Test Cups — MEDICAL DISTRIBUTION GROUP INC
- Identify® Diagnostics Drug Test Cups — MEDICAL DISTRIBUTION GROUP 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ucp Biosciences, Inc.
Sources (1)
- FDA UDI 5fb3ddb1-e83c-4895-b343-928173ed5b95 36 fields · synced Jun 8, 2026