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

Covid-19 Multi-Analyte Respiratory Panel Nucleic Acid Devices

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FDA source (opens on fda.gov)

QLT is the FDA product code for Covid-19 Multi-Analyte Respiratory Panel Nucleic Acid Devices. FDA's definition for this code reads: "Multi-analyte nucleic acid-based in vitro diagnostic devices for the simultaneous qualitative detection and differentiation of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), that causes COVID-19, and common respiratory microorganisms in human respiratory and/or acceptable clinical specimens collected...". As of , FDA records hold no 510(k) clearances under this code and 11 recalls.

Classification record

Product code
QLT
Device name
Covid-19 Multi-Analyte Respiratory Panel Nucleic Acid Devices
FDA definition
Multi-analyte nucleic acid-based in vitro diagnostic devices for the simultaneous qualitative detection and differentiation of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), that causes COVID-19, and common respiratory microorganisms in human respiratory and/or acceptable clinical specimens collected from individuals suspected of respiratory viral infection consistent with COVID-19 by a healthcare provider. Results should not be used as the sole basis for diagnosis, treatment or other patient management decisions and must be combined with clinical observations, patient history, and/or epidemiological information.
Device class
Not classified
Review panel
Unknown
Submission type
FDA code 8
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
11

Companies listing this code with FDA

Companies whose registered establishments list this code