iScreen™ ABTOFCUBE0604D

by Instant Technologies, Inc.

iScreen ABTOFCUBE0604D is a multiple drugs of abuse IVD (FDA Class II) made by Instant Technologies, Inc., listed in FDA GUDID since 1 May 2023 (UDI-DI 00817405023936), registry data as of 22 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00817405023936 UDI-DI	Date1 May 2023Listed	StatusListed GUDID: in commercial distribution

Official records

AccessGUDID record UDI-DI 00817405023936

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name: iScreen™
Generic name: Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Model / Ref / Catalog: ABTOFCUBE0604D
Description: 6 Panel E&I Oral Click Cube AMP50, BZO10, COC20, MET50, OPI40, OXY20

Primary DI / UDI-DI: 00817405023936
FDA product code: PUX, PUZ, PVA, PVD, PVH
GMDN term: Multiple drugs of abuse IVD, kit, rapid ICT, clinical

Device class: Class II
Regulation number: 862.3100, 862.3170, 862.3250, 862.3610, 862.3650
GUDID distribution status: In Commercial Distribution

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Properties

Single use
Convenience kit
Premarket exempt
Lot / batch number
Expiration date

Other properties (10, all answered No)