FDA-Device2012-10-31Class II
AdvanDx GNR Traffic Light PNA FISH, In Vitro Diagnostic for Culture Identification Kit for Escherichia coli,and/or Klebsiella pneumoniae and/or Pseudomonas aeruginosa Catalog number: KT011. GNR Traffic Light PNA FISH is a multicolor, qualitative nucleic acid hybridization assay intended for the identification of Escherichia coli,and/or Klebsiella pneumoniae and/or Pseudomonas aeruginosa on smears from positive blood cultures containing Gram-negative rods observed on Gram stain. Sub-culturin
Advandx Inc
Hazard
GNR Traffic Light PNA Fish may have false positive results with Pseudomonas putida and Pseudomonas fulva
Sold states
Worldwide Distribution-USA (nationwide) and the countries of Austria, Denmark, Italy, Germany, Finland, and UK.
Affected count
187 kits
Manufactured in
400 Tradecenter, Ste 6990, Woburn, MA, United States
Products
AdvanDx GNR Traffic Light PNA FISH, In Vitro Diagnostic for Culture Identification Kit for Escherichia coli,and/or Klebsiella pneumoniae and/or Pseudomonas aeruginosa Catalog number: KT011. GNR Traffic Light PNA FISH is a multicolor, qualitative nucleic acid hybridization assay intended for the identification of Escherichia coli,and/or Klebsiella pneumoniae and/or Pseudomonas aeruginosa on smears from positive blood cultures containing Gram-negative rods observed on Gram stain. Sub-culturing of positive blood cultures is necessary to recover organisms for susceptibility testing and/or differentiation of mixed growth. The GNR Traffic Light PNA FISH assay is indicated for use as an aid in the diagnosis of coli, and/or K. pneumoniae, and/or P. aeruginosa bacteremia.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0112-2013Don't want to check this manually?
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