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AdvanDx Receives FDA 510(k) Clearance for GNR Traffic Light™ PNA FISH®

AdvanDx has received FDA 510(k) clearance for its GNR Traffic Light™ PNA FISH® test. GNR Traffic Light PNA FISH is the first test capable of simultaneously identifying Escherichia coli, Klebsiella pneumoniae and Pseudomonas aeruginosa directly from positive blood cultures containing Gram-negative rods in less than 90 minutes.

The test is the latest addition to AdvanDx's easy-to-use, molecular-based PNA FISH diagnostics platform designed to provide rapid, therapy-guiding results that enable clinicians to provide early, effective therapy for patients with Gram-negative bloodstream infections (BSI).

Identification direct from postiive blood cultures

GNR Traffic Light PNA FISH will enable microbiology labs to identify and report E. coli, K. pneumoniae and P. aeruginosa from positive blood cultures 1 to 2 days earlier than traditional methods.

NOTE: This item is from our 'historic' database and may contain information which is not up to date.

Source : AdvanDx View archived contact details

Posted on January 18, 2011