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Bd Geneohm Cdiff Assay

by Bd Diagnostics (Geneohm Sciences, Inc.)

510(k) K081920

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

4 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 10 Oct 2026. What this means

Regulatory status

as of registry sync 10 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK081920 Date19 Dec 2008ClearedStatusActive

Recalls

4 recalls · FDA

    • Terminated Z-0790-2014 FDA Class II initiated 11 Oct 2013

    An incorrect reagent was packed with an in vitro diagnostic kit, which may cause an increase in unresolved results or false negative results for Clostridium difficile in patient samples.

  • 2 recalls, same reason

    • Terminated Z-2318-2012 FDA Class II initiated 22 May 2012
    • Terminated Z-2319-2012 FDA Class II initiated 22 May 2012

    Leakage in Cepheid SmartCycler reaction tubes.

    • Terminated Z-2174-2010 FDA Unclassified (pre-2012) initiated 5 Mar 2010

    In vitro diagnostic test kits do not perform to specifications.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
LLH
Device Class
Class I
Regulation
21 CFR Part 866.2660
Advisory Committee
Microbiology
FDA Decision
SESE Substantially Equivalent

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