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 Cup with 4 Panel Drug Screen for (COC/OPI2000/AMP/MET). FDA UDI
- Model / Reference
- USSCup-4NT FDA UDI
- Description
- U-Screen Squared Integrated Cup with 4 Panel Drug Screen for (COC/OPI2000/AMP/MET). FDA UDI
Identifiers
- Catalog Number
- USSCup-4NT FDA UDI
- Primary DI / UDI-DI
- 00817405021208 FDA UDI
- 510(k) Number
- K182701 FDA UDI
- FDA Product Code
- NGL FDA UDINGG FDA UDINFY 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
- 862.3650 FDA UDI862.3610 FDA UDI862.3250 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
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- 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 |
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Manufacturer
- Manufacturer
- Instant Technologies, Inc.
Sources (1)
- FDA UDI 6258ffd0-1756-42d4-880d-a629862706c9 37 fields · synced Jun 8, 2026