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UScreen®

FDA UDI

Class II (US FDA UDI)

by Instant Technologies, Inc.

Identity

Trade Name
UScreen® FDA UDI
Generic Name
Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI
Device Name
UScreen with 10 Panel Drug Screen for (THC/COC/OPI300/AMP/MET/BAR/BZO/MDMA/MTD/OXY) FDA UDI
Model / Reference
USSCup-10MMO300 FDA UDI
Description
UScreen with 10 Panel Drug Screen for (THC/COC/OPI300/AMP/MET/BAR/BZO/MDMA/MTD/OXY) FDA UDI

Identifiers

Catalog Number
USSCup-10MMO300 FDA UDI
Primary DI / UDI-DI
00817405021222 FDA UDI
510(k) Number
K182701 FDA UDI
FDA Product Code
PTG FDA UDI
PTH FDA UDI
NFW FDA UDI
NGL FDA UDI
NGG FDA UDI
NFY FDA UDI
NFV FDA UDI
NFT 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 UDI
862.3150 FDA UDI
862.3870 FDA UDI
862.3650 FDA UDI
862.3610 FDA UDI
862.3250 FDA UDI
862.3170 FDA UDI
862.3100 FDA UDI
Commercial Distribution
Not 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

UScreen® by Instant Technologies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K182701 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Instant Technologies, Inc.

Sources (1)

  • FDA UDI 8f1b8afd-2816-46a5-bc04-b3ff78ce7eeb 38 fields · synced May 30, 2026