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OC-Light FOBBTL

by Polymedco Cancer Diagnostic Products LLC

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

1 closed

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 Number00855574005070 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: not in commercial distribution

Recalls

1 recall · FDA

    • Terminated Z-1059-2013 FDA Class II initiated 12 Feb 2013

    The test strips in the affected product lots of the OC Light immunological fecal occult blood test are being recalled because they may not be stable through their labeled shelf-life. There may be a possibility of obtaining false negative results when using the affected lots.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
OC-Light
Generic Name
Faecal occult blood IVD, kit, rapid ICT, clinical
Model / Reference
FOBBTL
Primary DI / UDI-DI
00855574005070
510(k) Number
FDA Product Code
KHE
GMDN Term
Faecal occult blood IVD, kit, rapid ICT, clinical
Device Class
Class II
Regulation Number
864.6550
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (K041297)

Other devices from Polymedco Cancer Diagnostic Products LLC

See all devices from Polymedco Cancer Diagnostic Products LLC →

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