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OC-Auto OCPUIO-GSJH

by Polymedco Cancer Diagnostic Products LLC

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 Number00816917027753 UDI-DI Date13 Feb 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  • Withdrawn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

Trade Name
OC-Auto
Generic Name
Faecal occult blood IVD, reagent
Model / Reference
OCPUIO-GSJH
Primary DI / UDI-DI
00816917027753
510(k) Number
FDA Product Code
OOX
GMDN Term
Faecal occult blood IVD, reagent
Device Class
Class II
Regulation Number
864.6550
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K191147)

Show all (12)

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