Identity
- Trade Name
- UScreen® FDA UDI
- Generic Name
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- U-Screen Squared Integrated CLIA Waived Cup with Adulterants (CR,SG,PH) 12 Panel Drug Screen for (THC/COC/MOP/AMP/MET/PCP/BZO/BAR/BUP/MDMA/MTD/OXY) FDA UDI
- Model / Reference
- USSCupA-12BUP300CLIA FDA UDI
- Description
- U-Screen Squared Integrated CLIA Waived Cup with Adulterants (CR,SG,PH) 12 Panel Drug Screen for (THC/COC/MOP/AMP/MET/PCP/BZO/BAR/BUP/MDMA/MTD/OXY) FDA UDI
Identifiers
- Catalog Number
- USSCUPA-12BUP30 FDA UDI
- Primary DI / UDI-DI
- 00817405021178 FDA UDI
- 510(k) Number
- K182701 FDA UDI
- FDA Product Code
- PTG FDA UDIPTH FDA UDILCM FDA UDINFW FDA UDINGL FDA UDINGG FDA UDINFY FDA UDINFV FDA UDINFT 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 UDI862.3150 FDA UDI862.3870 FDA UDI862.3650 FDA UDI862.3610 FDA UDI862.3250 FDA UDI862.3170 FDA UDI862.3100 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
Yes
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
UScreen® by Instant Technologies, 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
K182701 also covers:
- T-Cup® Compact — Instant Technologies, Inc.
- T-Cup® Compact — Instant Technologies, Inc.
- T-Cup® Compact — Instant Technologies, Inc.
- T-Cup® Compact — Instant Technologies, Inc.
- UScreen® — Instant Technologies, Inc.
- UScreen® — Instant Technologies, Inc.
- UScreen® — Instant Technologies, Inc.
- UScreen® — Instant Technologies, Inc.
- UScreen® — Instant Technologies, Inc.
- UScreen® — Instant Technologies, Inc.
- UScreen® — Instant Technologies, Inc.
- UScreen® — Instant Technologies, 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
- Instant Technologies, Inc.
Sources (1)
- FDA UDI 00048000-af67-484a-b26a-c94cc1079df1 37 fields · synced May 31, 2026