FDA Product Code QBH: Lower Respiratory Microbial Nucleic Acid Detection System
Device To Detect And Identify Microorganisms And Associated Resistance Marker Nucleic Acids Directly In Respiratory Specimens.
Leading manufacturers include Curetis GmbH.
2
Total
1
Cleared
177d
Avg days
2018
Since
FDA 510(k) Cleared Lower Respiratory Microbial Nucleic Acid Detection System Devices (Product Code QBH)
2 devices
Cleared
Dec 20, 2019
Unyvero LRT BAL Application
Curetis GmbH
Microbiology
150d
Not Cleared
Apr 03, 2018
Curetis Unyvero LRT Application
Curetis GmbH
Microbiology
204d