Skip to content

Leakbuster B1202-1OTS

by Starplex Scientific, 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 Number10840165500666 UDI-DI Date7 Oct 2025ListedStatusListed 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  • Withdrawn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
Leakbuster
Generic Name
Drug-testing urine specimen container IVD
Model / Reference
B1202-1OTS
Primary DI / UDI-DI
10840165500666
FDA Product Code
FMH
GMDN Term
Drug-testing urine specimen container IVD
Device Class
Class I
Regulation Number
864.3250
GUDID distribution status
In Commercial Distribution

Other devices from Starplex Scientific, Inc.

See all devices from Starplex Scientific, Inc. →

Properties

  • Sterile
  • Single Use
  • Premarket Exempt

Other properties (11)

  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Lot / Batch Number: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No