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Idi-Mrsa Assay

by Infectio Diagnostic (I.D.I.), Inc.

510(k) K042357

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

3 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 11 Oct 2026. What this means

Regulatory status

as of registry sync 11 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK042357 Date22 Oct 2004ClearedStatusActive

Recalls

3 recalls · FDA

    • Terminated Z-1963-2009 FDA Unclassified (pre-2012) initiated 11 Nov 2008

    BD Diagnostics GeneOhm (BDDG) has determined that the Cepheid SmartCycler reaction tubes packaged in the BD GeneOhm MRSA test kits identified above may be defective.

  • 2 recalls, same reason

    • Terminated Z-0226-2009 FDA Unclassified (pre-2012) initiated 21 Jul 2008
    • Terminated Z-0225-2009 FDA Unclassified (pre-2012) initiated 21 Jul 2008

    BD Diagnostics GeneOhm (BDDG) initiated the recall after they identified that the product has the potential to identify a patient as falsely positive for colonization with methicillin resistant Staphylococcus aureus. The potential health hazard related to a false positive result from this assay would be that a patient may be misclassified as having MRSA colonization when in fact they do not have

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  • Withdrawn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
NQX
Device Class
Class II
Regulation
21 CFR Part 866.1640
Advisory Committee
Microbiology
FDA Decision
SESE Substantially Equivalent

Other devices from Infectio Diagnostic (I.D.I.), Inc.

  • Idi-Mrsa

    Class II

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    Class I