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iScreenTM Oral Fluid Drug Test ABTDCTCUBO0102

by Hangzhou AllTest Biotech Co., Ltd.

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

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06936983197090 UDI-DI Date26 Sep 2025ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
iScreenTM Oral Fluid Drug Test
Generic Name
Cotinine IVD, kit, rapid ICT, clinical
Model / Reference
ABTDCTCUBO0102
Primary DI / UDI-DI
06936983197090
FDA Product Code
MRS
GMDN Term
Cotinine IVD, kit, rapid ICT, clinical
Device Class
Class I
Regulation Number
862.3220
GUDID distribution status
In Commercial Distribution

Other devices from Hangzhou Alltest Biotech.Co., Ltd.

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Properties

  • Single Use
  • Premarket Exempt
  • Lot / Batch Number

Other properties (11)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No