DeviceClearance

Product code SIA— Microbiology

Visby Medical Flu and COVID-19 Test

Classification name
Over-The-Counter Molecular Multi-Analyte Respiratory Virus Detection Test
Device class
Class 2
Regulation
21 CFR 866.3984
Advisory panel
Microbiology
Total cleared
1
First cleared
Most recent

FDA classification definition

“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.”

— U.S. Food and Drug Administration, device classification record for product code SIA under 21 CFR 866.3984, via openFDA

Market context for product code SIA

FDA has cleared 1 device under product code SIA, all in 2026, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code SIA

Recent clearances under product code SIA

Data sourced from openFDA. This site is unofficial and independent of the FDA.