FebriDx Bacterial/Non-bacterial Assay
K-Number: K260787 · 2026-03-24
ApplicantLumos Diagnostics, Inc.
Decision Date2026-03-24
Product CodeQXA
Advisory CommitteeMI
DecisionSubstantially Equivalent
Device Summary
FebriDx Bacterial/Non-bacterial Assay is a medical device manufactured by Lumos Diagnostics, Inc.. It received FDA 510(k) clearance on 2026-03-24 under approval number K260787. The device is classified under product code QXA. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the FebriDx Bacterial/Non-bacterial Assay?
FebriDx Bacterial/Non-bacterial Assay is a medical device that received FDA 510(k) clearance on 2026-03-24. It is manufactured by Lumos Diagnostics, Inc.. The 510(k) number is K260787.
When was FebriDx Bacterial/Non-bacterial Assay approved by the FDA?
FebriDx Bacterial/Non-bacterial Assay received FDA 510(k) clearance on 2026-03-24, under approval number K260787.
What company makes FebriDx Bacterial/Non-bacterial Assay?
FebriDx Bacterial/Non-bacterial Assay is manufactured by Lumos Diagnostics, Inc..
What is the FDA product code for FebriDx Bacterial/Non-bacterial Assay?
The FDA product code for FebriDx Bacterial/Non-bacterial Assay is QXA.
Other Devices by Lumos Diagnostics, Inc.
Related Devices (Code: QXA)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.