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AlereTM iScreen® IS2CT

by Instant Technologies, Inc.

AlereTM iScreen IS2CT is a multiple drugs of abuse IVD (FDA Class II) made by Instant Technologies, Inc., listed in FDA GUDID since 24 Sep 2016 (UDI-DI 10858945006444), registry data as of 23 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

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10858945006444 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
AlereTM iScreen®
Generic name
Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Model / reference
IS2CT
Primary DI / UDI-DI
10858945006444
FDA product code
LFG, LDJ, LCM, JXN, JXM, DKZ, DJR, DJG, DJC, DIS, DIO
GMDN term
Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Device class
Class II
Regulation number
862.3910, 862.3870, 862.3700, 862.3170, 862.3100, 862.3620, 862.3650, 862.3610, 862.3150, 862.3250
GUDID distribution status
In Commercial Distribution

Related devices

Category: Multiple drugs of abuse IVD, kit, rapid ICT, clinical

Similar devices

Other devices filed under FDA product code LFG (Radioimmunoassay, Tricyclic Antidepressant Drugs).

Other devices from Instant Technologies, Inc.

See all devices from Instant Technologies, Inc. →

Properties

  • Single use
  • Lot / batch number
  • Expiration date
Other properties (12, all answered No)