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Analysis Oasis Global LLC

by Analysis Oasis Global LLC 5 variants

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

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 Number00850086569003 UDI-DI Date10 Jun 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Generic Name
Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Model / Ref / Catalog
Marijuana(THC) Urine Test Dip Card 3-Pack, SINGLE-THC-DIP-3
Primary DI / UDI-DI
00850086569003
510(k) Number
FDA Product Code
LDJ
GMDN Term
Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Device Class
Class II
Regulation Number
862.3870
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K153646)

Other devices from Analysis Oasis Global LLC

Properties

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

Other properties (10)

  • Sterile: 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