SIAClass II
Over-the-counter Molecular Multi-analyte Respiratory Virus Detection Test
Microbiology · 21 CFR 866.3984
An over-the-counter molecular multi-analyte respiratory virus detection test is an in vitro diagnostic device for the detection and/or differentiation of respiratory viruses directly from clinical specimens. The device is intended to be used by lay users and without health care provider (HCP) intervention in home settings or similar environments.
MDR events0All time
Recalls0All time
Registered firms0Currently listed
510(k) clearances1All time
Recent MDR events
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Event type breakdown
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Recalls
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No recalls on file for this product code.
Registered firms
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No registered firms found for this product code.
510(k) clearances
1 clearances for this product code