QMN
- Product code
- QMN
- Device name
- Covid-19 Multi-Analyte Antigen Device
- Device class
- Class N
- Medical specialty
- Unknown
- Marketing pathway
- EUA - Emergency Use Authorization
FDA classification definition
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.
Official FDA classification page: QMN
Classification and pathway per current FDA publications. Data from openFDA (CC0).