FDA Product Code QDP: Respiratory Panel
The Panel Is A Multiplexed Nucleic Acid Test Intended For Use With Systems For The Simultaneous Detection And Identification Of Multiple Respiratory Viral And Bacterial Nucleic Acids, As Well As Select Antimicrobial Resistance Genes, In Sputum-like Specimens (induced Or Expectorated Sputum, Or Endotracheal Aspirates) Or Bronchoalveolar Lavage (bal)-like Specimens (bal Or Mini-bal) Obtained From Individuals Suspected Of Lower Respiratory Tract Infection.
Leading manufacturers include Biofire Diagnostics, LLC.
FDA 510(k) Cleared Respiratory Panel Devices (Product Code QDP)
About Product Code QDP - Regulatory Context
510(k) Submission Activity
2 total 510(k) submissions under product code QDP since 2018, with 2 receiving FDA clearance (average review time: 118 days).
Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.
QDP devices are reviewed by the Microbiology panel. Browse all Microbiology devices →