Covid-19 Multi-Analyte Respiratory Panel Nucleic Acid Devices
The COVID-19 Multi-Analyte Respiratory Panel Nucleic Acid Device is a not-classified in vitro diagnostic device using nucleic acid-based technology for the simultaneous qualitative detection and differentiation of SARS-CoV-2 and common respiratory microorganisms in human respiratory specimens, authorized under Emergency Use Authorization during the COVID-19 public health emergency; results are not intended to be used as the sole basis for diagnosis or patient management decisions. The product code is QLT, reviewed by the Microbiology panel. The device is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- QLT
- Device Class
- FDA not classified
- Medical Specialty
- Unknown
- Review Panel
- MI
- Submission Type
- 8
Device Characteristics
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.
Unclassified Reason
11
FEI Numbers
This FDA classification entry is associated with 9 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 9 registration numbers. Click on an entry to view related FDA registrations.