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510(k) K110203

XPERT C. DIFFICLE/EPI ASSAY by Cepheid — Product Code OMN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 7, 2011
Date Received
January 24, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
C. Difficile Nucleic Acid Amplification Test Assay
Device Class
Class I
Regulation Number
866.2660
Review Panel
MI
Submission Type

In vitro diagnostic test for the qualitative detection of toxigenic clostridium difficile nucleic acids isolated and purified from stool specimens obtained from symptomatic patients.

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Other clearances for product code OMN

  • DEN120013 — PORTRAIT ANALYZER (April 30, 2012)
  • K113433 — SIMPLEXA C. DIFFICILE UNIVERSAL DIRECT (April 4, 2012)
  • K110012 — ILLUMIGENE C. DIFFICILE, AND ILLUMIPRO-10 (February 24, 2011)
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