QLT · Covid-19 Multi-Analyte Respiratory Panel Nucleic Acid Devices
· Class N
Overview
| Product Code | QLT |
|---|---|
| Device Name | Covid-19 Multi-Analyte Respiratory Panel Nucleic Acid Devices |
| Device Class | Class N |
| Review Panel |
Identification
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.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
