Skip to content

ToxCup Drug Screen Cup HT15A

by Branan Medical Corp.

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

2 closed

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 Number00816555020369 UDI-DI Date1 Aug 2016ListedStatusListed GUDID: not in commercial distribution

Recalls

2 recalls · FDA

    • Terminated Z-3045-2020 FDA Class II initiated 18 Aug 2020

    Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling.

    • Terminated Z-1508-2014 FDA Class II initiated 26 Mar 2014

    May be labeled with incorrect result interpretation graphics on the ToxCup lid label.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
ToxCup Drug Screen Cup
Generic Name
Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Model / Ref / Catalog
HT15A
Primary DI / UDI-DI
00816555020369
510(k) Number
FDA Product Code
DJG, LDJ, LCM, DJC, DIO, DKZ
GMDN Term
Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Device Class
Class II
Regulation Number
862.3650, 862.3870, 862.3610, 862.3250, 862.3100
GUDID distribution status
Not in Commercial Distribution

Other devices from Branan Medical Corp.

See all devices from Branan Medical Corp. →

Properties

  • Single Use
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date

Other properties (9)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No