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iScreen™

FDA UDI

Class II (US FDA UDI)

by Instant Technologies, Inc.

Identity

Trade Name
iScreen™ FDA UDI
Generic Name
Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI
Device Name
6 PANEL E&I OF CUBE AMP50/BAR20/COC20/OPI40/PCP10/THC40 FDA UDI
Model / Reference
ABTOFCUBE0601A FDA UDI
Description
6 PANEL E&I OF CUBE AMP50/BAR20/COC20/OPI40/PCP10/THC40 FDA UDI

Identifiers

Catalog Number
ABTOFCUBE0601A FDA UDI
Primary DI / UDI-DI
00817405023523 FDA UDI
FDA Product Code
PUX FDA UDI
PUY FDA UDI
PVA FDA UDI
PVH FDA UDI
LCM FDA UDI
PVJ 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 UDI
862.3150 FDA UDI
862.3250 FDA UDI
862.3650 FDA UDI
862.3870 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

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

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

Similar devices

Also classified as Multiple drugs of abuse IVD, kit, rapid ICT, clinical.

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 74f03d57-8116-40fa-8e09-959ec597f982 36 fields · synced May 30, 2026