510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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QDPClass II

Respiratory Panel

21 CFR 866.3985 / Microbiology
FDA source (opens on fda.gov)

QDP is the FDA product code for Respiratory Panel, a class II device type, regulated under 21 CFR 866.3985. FDA's definition for this code reads: "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)...". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
QDP
Device name
Respiratory Panel
FDA 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.
Regulation
21 CFR 866.3985
Device class
Class II
Review panel
Microbiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
0

Clearances, product code QDP

By decision year
2 clearances under product code QDP with a decision year between 2018 and 2021, 2018 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QDP by decision year
YearClearances
20181
20211

Applicants with the most clearances

Product code QDP
Applicants holding the most 510(k) clearances under product code QDP
ApplicantClearances
BioFire Diagnostics, LLC2

Companies listing this code with FDA

Companies whose registered establishments list this code