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