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First Check(R) 14 Drug Test

by First Check Diagnostic Corp. GUDID

Withdrawn United States

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00643281710055 UDI-DIDate11 Apr 2018ListedStatusWithdrawn

Coverage

1 jurisdiction

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

United States — GUDID listing Listed

Recalls

8 recalls · FDA

  • 8 recalls, same reason

    • Terminated Z-3047-2020 FDA Class II initiated 18 Aug 2020
    • Terminated Z-3033-2020 FDA Class II initiated 18 Aug 2020
    • Terminated Z-3032-2020 FDA Class II initiated 18 Aug 2020
    • Terminated Z-3040-2020 FDA Class II initiated 18 Aug 2020
    • Terminated Z-3031-2020 FDA Class II initiated 18 Aug 2020
    • Terminated Z-3035-2020 FDA Class II initiated 18 Aug 2020
    • Terminated Z-3039-2020 FDA Class II initiated 18 Aug 2020
    • 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.

Specification

GUDID

Trade Name
First Check(R)
Generic Name
Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Model / Reference
14 Drug Test
Primary DI / UDI-DI
00643281710055
510(k) Number
FDA Product Code
LFG, QAW, JXN, QBF, LCM, NGM, NGG, DJC, DJR, PTG, NFY, DIO, NFT, DKZ, PTH, DIS, NFV, JXM, NGI, NGL, DJG, DNK, NFW, LDJ
GMDN Term
Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Device Class
Class II
Regulation Number
862.3910, 862.3700, 862.3610, 862.3620, 862.3250, 862.3100, 862.3150, 862.3170, 862.3640, 862.3650, 862.3870
Commercial Distribution
Not in Commercial Distribution

Related devices

Cleared under the same submission (K122633)

Show all (11)

Properties

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

Other properties (9)

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