Skip to content

DrugCheck 60513-6

by Express Diagnostic Int'l, Inc.

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberB2986051360 UDI-DI Date20 Feb 2026ListedStatusListed 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  • Withdrawn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
DrugCheck
Generic name
Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Model / Ref / Catalog
60513-6
Primary DI / UDI-DI
B2986051360
FDA product code
DKZ, DIO, LAF, DJG, LCM
GMDN term
Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Device class
Class II
Regulation number
862.3100, 862.3250, 862.3610, 862.3650
GUDID distribution status
In Commercial Distribution

Other devices from Express Diagnostic Int'l, Inc.

See all devices from Express Diagnostic Int'l, Inc. →

Properties

  • Single use
  • Over-the-counter
  • Lot / batch number
  • Expiration date

Other properties (11)

  • Supplied sterile: No
  • Sterilise before use: 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