Product code NHT— Microbiology

“An invitro diagnostic device used to presumptively detect the presence or absence of b. Anthracis directly in blood specimens or suspicious culture growth.”

FDA has cleared 6 devices under product code NHT between 2005 and 2019, filed by 4 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.

• 20191 clearance
• 20141 clearance
• 20131 clearance
• 20072 clearances
• 20051 clearance

• Idaho Technology, Inc.3 clearances
• Centers For Disease Control and Prevention (CDC)1 clearance
• Centers for Disease Control and Prevention1 clearance
• Biofire Diagnostics, Inc.1 clearance

• K192871 — B. anthracis Real-time PCR AssayCenters for Disease Control and Prevention·2019-11-07
• K140426 — ANTHRACIS REAL-TIME PCR ASSAYCenters For Disease Control and Prevention (CDC)·2014-05-22
• K131930 — JBAIDS ANTHRAX DETECTION KITBiofire Diagnostics, Inc.·2013-08-05
• K072631 — JBAIDS PLAQUE DETECTION KIT, MODEL JRPD-ASY-0123Idaho Technology, Inc.·2007-12-20
• K071188 — MODIFICATION TO JBAIDS ANTHRAX DETECTION SYSTEMIdaho Technology, Inc.·2007-05-21
• K051713 — JBAIDS ANTHRAC DETECTION SYSTEMIdaho Technology, Inc.·2005-11-18