Visby Medical Respiratory Health Test
FDA 510(k) K242526 · Visby Medical, Inc.
Submission
- Device name
- Visby Medical Respiratory Health Test
- Applicant
- Visby Medical, Inc.
San Jose, CA, US - Received
- August 26, 2024
- Decision date
- February 19, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Dual Track 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QOF – Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3981
- Specialty
- Microbiology
A device to detect and identify nucleic acid targets in respiratory specimens from microbial agents that cause the SARS-CoV-2 respiratory infection and other microbial agents when in a multi-target test is an in vitro diagnostic device intended for the detection and identification of SARS-CoV-2 and other microbial agents when in a multi-target test in human clinical respiratory specimens from…
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| K252932 | Fast PCR Mini Respiratory PanelQOF · Dual Track | Autonomous Medical Devices Incorporated | 06/12/2026SE |
| K252269 | FINDER Flu A&B/SARS-CoV-2 TestQOF · Dual Track | Baebies, Inc. | 03/30/2026SE |
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| K251978 | Liaison Nes Flu A/B, RSV & COVID-19QOF · Dual Track | Diasorin Molecular, LLC | 12/23/2025SE |
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| K243455 | cobas Respiratory 4-flex for use on the cobas 5800/6800/8800 SystemsQOF · Traditional | Roche Molecular Systems, Inc. | 07/31/2025SE |
| K250996 | Xpert Xpress CoV-2/Flu/RSV plusQOF · Special | Cepheid® | 05/01/2025SE |
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Questions and answers
When was Visby Medical Respiratory Health Test cleared by the FDA?
Visby Medical Respiratory Health Test (K242526) received a 510(k) decision of Substantially Equivalent on February 19, 2025, 177 days after the submission was received.
What is the product code of K242526?
The FDA product code is QOF – Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents, a Class II (moderate risk) device regulated under 21 CFR 866.3981.