FDA-Device2014-01-08Class III
AdvanDx Gram-Negative QuickFISH BC. In-Vitro Diagnostic for the identification of Enterobacteriacae Catalog Number: QFGNRBC1-25 Gram-Negative QuickFISH BC provides rapid identification of Escherichia coli, and/or Pseudomonas aeruginosa, and/or Klebsiella pneumoniae directly from GNR-positive blood cultures
AdvanDx, Inc.
Hazard
Kits incompatible with certain fluorescence microscope light sources
Sold states
Worldwide Distribution - USA including CA, IL, IN, OH, NJ, MI , MO, NY, WI. Internationally to Denmark.
Affected count
49 kits US; 17 kits OUS
Manufactured in
10a Roessler Rd, Woburn, MA, United States
Products
AdvanDx Gram-Negative QuickFISH BC. In-Vitro Diagnostic for the identification of Enterobacteriacae Catalog Number: QFGNRBC1-25 Gram-Negative QuickFISH BC provides rapid identification of Escherichia coli, and/or Pseudomonas aeruginosa, and/or Klebsiella pneumoniae directly from GNR-positive blood cultures
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0619-2014Don't want to check this manually?
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