Identity
- Trade Name
- Premier Bio-Cup & Bio-Dip FDA UDI
- Generic Name
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- PCP25 FDA UDI
- Model / Reference
- PBCard-01-PCP FDA UDI
- Description
- PCP25 FDA UDI
Identifiers
- Catalog Number
- PBCard-01-PCP FDA UDI
- Primary DI / UDI-DI
- B313PBCARD01PCP1 FDA UDI
- FDA Product Code
- LCM FDA UDI
- GMDN Term
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI
Classification
- Device Class
- U 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
No
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
Premier Bio-Cup & Bio-Dip by Premier Biotech, LLC — Class U — 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
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 U | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Premier Biotech, LLC
Sources (1)
- FDA UDI 9536dc3d-3dd2-4689-a4fa-e652df9c5f11 36 fields · synced May 29, 2026