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510(k) K123905

CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL by Centers For Disease Control and Prevention — Product Code OQW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 14, 2013
Date Received
December 19, 2012
Clearance Type
Special
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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