Product code NXD— Microbiology

“Novel influenza a virus reagents are used in nucleic acid amplification tests to directly detect and differentiate novel influenza a virus specific rna gene segments in human respiratory specimens or viral cultures. Detection and differentiation of specific rna gene segments aids in the diagnosis of influenza caused by novel influenza a viruses in patients with clinical and epidemiological risk of infection with these viruses. They also aid in the presumptive identification of specific novel influenza a viruses and provide epidemiological information on influenza. These reagents are primers and probes, along with a specific novel influenza virus control.”

FDA has cleared 3 devices under product code NXD between 2006 and 2010, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 20101 clearance
• 20081 clearance
• 20061 clearance

• Centers for Disease Control and Prevention2 clearances
• U.S. Army Medical Material Development Command1 clearance

• K100287 — JBAIDS INFLUENZA A/H5 DETECTION KIT, MODEL JRPD-ASY-0136U.S. Army Medical Material Development Command·2010-07-06
• K080570 — CDC HUMAN INFLUENZA VIRUS REAL-TIME RT- PCR DETECTION AND CHARACTERIZATION PANELCenters for Disease Control and Prevention·2008-09-30
• DEN060008 — INFLUENZA A/H5 (ASIAN LINEAGE) VIRUS REAL-TIME RT-PCR PRIMER AND PROBE SETCenters for Disease Control and Prevention·2006-02-03