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Respiratory Panel

FDA product code QDP · 2 cleared devices

Class 2 Microbiology
Regulation
21 CFR 866.3985
Review panel
MI
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2018-11-09 – 2021-09-22

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.

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