Covid-19 Multi-Analyte Antigen Device
The COVID-19 Multi-Analyte Antigen Device is a qualitative in vitro diagnostic test for the detection of SARS-CoV-2 and other common respiratory microorganisms from human respiratory or acceptable clinical specimens collected from individuals suspected of respiratory viral infection, intended for use by healthcare providers. It was authorized under an FDA Emergency Use Authorization (EUA) and is therefore not formally classified by device class. Product code QMN, reviewed by the Microbiology panel. The device is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- QMN
- Device Class
- FDA not classified
- Medical Specialty
- Unknown
- Review Panel
- MI
- Submission Type
- 8
Device Characteristics
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.
Unclassified Reason
11
FEI Numbers
This FDA classification entry is associated with 26 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 26 registration numbers. Click on an entry to view related FDA registrations.