FDA 510(k) Applications for Medical Device Product Code "NXD"
(Nucleic Acid Amplification, Novel Influenza A Virus, A/H5 (Asian Lineage) Rna)

FDA 510(k) Number Applicant Device Name Decision Date
K080570 CENTERS FOR DISEASE CONTROL AND PREVENTION CDC HUMAN INFLUENZA VIRUS REAL-TIME RT- PCR DETECTION AND CHARACTERIZATION PANEL 09/30/2008
DEN060008 CENTERS FOR DISEASE CONTROL AND PREVENTION INFLUENZA A/H5 (ASIAN LINEAGE) VIRUS REAL-TIME RT-PCR PRIMER AND PROBE SET 02/03/2006
K100287 U.S. ARMY MEDICAL MATERIAL DEVELOPMENT COMMAND JBAIDS INFLUENZA A/H5 DETECTION KIT, MODEL JRPD-ASY-0136 07/06/2010


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