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RealityCHECKTM RC10KC

by Wolfe & Associates Inc

Listed FDA GUDID listing, not in commercial distribution

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 Number10868401000220 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: not 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  • Withdrawn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
RealityCHECKTM
Generic Name
Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Model / Reference
RC10KC
Primary DI / UDI-DI
10868401000220
FDA Product Code
LFG, LDJ, LCM, JXN, JXM, DKZ, DJR, DJG, DJC, DIS, DIO
GMDN Term
Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Device Class
Class II
Regulation Number
862.3910, 862.3870, 862.3700, 862.3170, 862.3100, 862.3620, 862.3650, 862.3610, 862.3150, 862.3250
GUDID distribution status
Not in Commercial Distribution

Properties

  • Single Use
  • Lot / Batch Number
  • Expiration Date

Other properties (11)

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