Respiratory Panel
The Respiratory Panel is a multiplexed nucleic acid test intended for simultaneous detection and identification of multiple respiratory viral and bacterial nucleic acids, as well as select antimicrobial resistance genes, in sputum-like specimens or bronchoalveolar lavage specimens from individuals suspected of lower respiratory tract infection. It is classified as FDA Class 2, requiring 510(k) premarket notification under regulation 866.3985 in the Microbiology specialty. The product code is QDP. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- QDP
- Device Class
- FDA class 2
- Regulation Number
- 866.3985
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
Definition
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.