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DrugTect Multi-Drug Urine Test Cup DT-AT18-FLAT-1-AZ1

by Hangzhou AllTest Biotech Co., Ltd.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number16942598201791 UDI-DI Date15 Nov 2025ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
DrugTect Multi-Drug Urine Test Cup
Generic Name
Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Model / Reference
DT-AT18-FLAT-1-AZ1
Primary DI / UDI-DI
16942598201791
510(k) Number
FDA Product Code
NFT, PTH, NGL, NFV, NFY, NGG, NGI, PTG, NFW, QBF
GMDN Term
Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Device Class
Class II
Regulation Number
862.3100, 862.3150, 862.3650, 862.3170, 862.3250, 862.3610, 862.3640, 862.3620, 862.3870, 862.3700
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K250727)

Show all (12)

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Properties

  • Single Use
  • Over-the-Counter
  • Lot / Batch Number

Other properties (11)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No