510(k) K101564

CDC INFLUENZA 2009 A(H1N1)PDM REAL-TIME RT-PCR PANEL by Centers For Disease Control and Prevention — Product Code OQW

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: June 22, 2010
Date Received: June 4, 2010
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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