Identity
- Trade Name
- iScreen™ FDA UDI
- Generic Name
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- 11 PNL CLIA WAIVED SQUARE CUP AMP 500, BAR 300, BUP 10, BZO 300, COC 150, MDMA 500, MET 500, MOP 300, MTD 300, OXY 100, THC 50 SVT (CR,NI,OX,pH,S.G.) FDA UDI
- Model / Reference
- ABTDUAW111701A FDA UDI
- Description
- 11 PNL CLIA WAIVED SQUARE CUP AMP 500, BAR 300, BUP 10, BZO 300, COC 150, MDMA 500, MET 500, MOP 300, MTD 300, OXY 100, THC 50 SVT (CR,NI,OX,pH,S.G.) FDA UDI
Identifiers
- Catalog Number
- ABTDUAW111701A FDA UDI
- Primary DI / UDI-DI
- 00817405023356 FDA UDI
- 510(k) Number
- K182701 FDA UDI
- FDA Product Code
- NFT FDA UDIPTH FDA UDINGL FDA UDINFV FDA UDINFY FDA UDINGG FDA UDIPTG FDA UDINFW FDA UDI
- GMDN Term
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3100 FDA UDI862.3150 FDA UDI862.3650 FDA UDI862.3170 FDA UDI862.3250 FDA UDI862.3610 FDA UDI862.3620 FDA UDI862.3870 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
iScreen™ by Instant Technologies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Multiple drugs of abuse IVD, kit, rapid ICT, clinical.
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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 2feaf7d3-3081-41d4-a433-ebb433e2df14 37 fields · synced May 30, 2026