> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Clears Visby Respiratory Health Test
- URL: https://www.fdaweb.com/fda-clears-visby-respiratory-health-test/
- Published: 2025-02-27T12:00:00.000Z
- Updated: 2026-09-14T14:54:09.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158741

FDA has cleared a Visby Medical 510(k) for its point-of-care respiratory health test. The [Visby Medical Respiratory Health Test](https://www.visbymedical.com/respiratory-health-test/?ref=fdaweb.com) is described as a rapid polymerase chain reaction test that detects and differentiates between upper respiratory infections caused by influenza A & B, and SARS-CoV-2 (Covid-19). The company says the multiplexed molecular device is the first handheld test to receive clearance after being granted an Emergency Use Authorization 12/2022\. It provides accurate results in under 30 minutes at the point of care, enabling clinicians to accurately diagnose and treat patients even in remote care facilities and other resource-limited healthcare settings, Visby says.