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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 Oral Click Cube AMP50, BZO10, COC20, MET50, OPI40, OXY20 FDA UDI
Model / Reference
ABTOFCUBE0604D FDA UDI
Description
6 Panel E&I Oral Click Cube AMP50, BZO10, COC20, MET50, OPI40, OXY20 FDA UDI

Identifiers

Catalog Number
ABTOFCUBE0604D FDA UDI
Primary DI / UDI-DI
00817405023936 FDA UDI
FDA Product Code
PUX FDA UDI
PUZ FDA UDI
PVA FDA UDI
PVD FDA UDI
PVH 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
862.3170 FDA UDI
862.3250 FDA UDI
862.3610 FDA UDI
862.3650 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 c06e0c03-7e68-4d9b-b1c6-0d1b171bfeb2 36 fields · synced Jun 6, 2026