Covid-19 Multi-Analyte Antigen Device
- US Product Code (FDA)
- QMNView Product Code Classification →
- US Risk Class (FDA)
- Class N
- US Regulation (CFR)
- 21 CFRView CFR Regulation →
- Medical specialty
- Unknown
- GMP exempt
- No
- Implantable
- No
- Life-sustaining
- No
- Third party review
- Not Eligible
A COVID-19 Multi-Analyte Antigen Device is a test for the qualitative detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) 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 interpreted in the context of clinical observations, patient history, and/or epidemiological information, patient history, and/or epidemiological information.
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Covid-19 Multi-Analyte Antigen Device is a medical device type in the Unknown specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.
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