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iScreen™ DTH-114

by Instant Technologies, Inc.

iScreen DTH-114 is a multiple drugs of abuse IVD (FDA Class II; FDA product code LDJ, Enzyme Immunoassay, Cannabinoids) made by Instant Technologies, Inc., listed in FDA GUDID since 7 Feb 2023 (UDI-DI 00817405022311), 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

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00817405022311 UDI-DI Date7 Feb 2023ListedStatusListed 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  • Withdrawn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
iScreen™
Generic name
Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Model / Ref / Catalog
DTH-114
Primary DI / UDI-DI
00817405022311
FDA product code
LDJ
GMDN term
Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Device class
Class II
Regulation number
862.3870
GUDID distribution status
In Commercial Distribution

Related devices

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

Similar devices in this category

Other devices filed under Multiple drugs of abuse IVD, kit, rapid ICT, clinical.

Other devices from Instant Technologies, Inc.

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Properties

  • Single use
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)