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510(k) K120911

XPERT FLU GENEXPERT DX SYSTEMS (GX-I, GX-IV) by Cepheid — Product Code OQW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 18, 2012
Date Received
March 26, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification
Device Class
Class II
Regulation Number
866.3332
Review Panel
MI
Submission Type

2009 H1N1 influenza virus detection and identification reagents are used to directly detect and differentiate the 2009 H1N1 influenza virus in human respiratory specimens

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Other clearances for product code OQW

  • K132237 — PRODESSE PROFAST+ ASSAY (August 26, 2013)
  • K130551 — CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL (May 22, 2013)
  • K123905 — CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL (January 14, 2013)
  • K111778 — JBAIDS INFLUENZA A SUBTYPING KIT (September 13, 2011)
  • K111507 — CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL (August 23, 2011)
  • K103766 — XPERT FLU, GENEXPERT DX SYSTEMS, GENEXPERT INFINITY SYSTEM, GENEXPERT SYSTEM SOF (April 21, 2011)
  • K101855 — PROFAST+ ASSAY (July 23, 2010)
  • K101564 — CDC INFLUENZA 2009 A(H1N1)PDM REAL-TIME RT-PCR PANEL (June 22, 2010)
  • K100148 — SIMPLEXA INFLUENZA A H1N1 (2009) MODEL MOL2500 (May 24, 2010)