QLT — Covid-19 Multi-Analyte Respiratory Panel Nucleic Acid Devices Class N
FDA product code QLT covers "Covid-19 Multi-Analyte Respiratory Panel Nucleic Acid Devices", a Class N medical device. Submissions are reviewed by the Unknown panel.
Classification Details
- Product Code
- QLT
- Device Class
- Class N
- Regulation Number
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Unknown
- Implant
- No
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.