Skip to content

Multi-Drug 12 Drugs Rapid Test Cup (Urine)

by Hangzhou AllTest Biotech Co., Ltd. 2 variants

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 Number16936983179963 UDI-DI Date14 Apr 2026ListedStatusListed 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  • Withdrawn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

Generic Name
Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Model / Ref / Catalog
1, DOA-A1127C
Primary DI / UDI-DI
16936983179963
510(k) Number
FDA Product Code
NFT, NGL, NFY, NGM, NFW, QAW, NFV, PTH, NGG, PTG
GMDN Term
Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Device Class
Class II
Regulation Number
862.3100, 862.3650, 862.3250, 862.3870, 862.3910, 862.3170, 862.3150, 862.3610, 862.3620
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K233019)

Show all (12)

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

See all devices from Hangzhou Alltest Biotech.Co., Ltd. →

Properties

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

Other properties (10)

  • 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
  • Manufacturing Date: No