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Healgen HDOA-264

by Healgen Scientific Limited Liability Company 2 variants

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00810173655682 UDI-DI Date4 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  • Withdrawn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
Healgen
Generic Name
Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Model / Reference
HDOA-264
Description
K240686 6 Panel Drug Dip Card: AMP1000, BZO300, COC300, MET1000, OPI2000, THC50
Primary DI / UDI-DI
00810173655682
FDA Product Code
LFG, LCM, DJR, DIS, JXM, DJG, LAF, DIO, LDJ, DKZ, JXN
GMDN Term
Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Device Class
Class II
Regulation Number
862.3910, 862.3620, 862.3150, 862.3170, 862.3650, 862.3610, 862.3250, 862.3870, 862.3100, 862.3700
GUDID distribution status
In Commercial Distribution

Other devices from Healgen Scientific Limited Liability Company

See all devices from Healgen Scientific Limited Liability Company →

Properties

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

Other properties (9)

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