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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Lumos Diagnostics, Inc.. It received FDA 510(k) clearance on 2026-03-24 under 510(k) 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. The listed applicant is Lumos Diagnostics, Inc.. The 510(k) number is K260787.

When did FebriDx Bacterial/Non-bacterial Assay receive FDA 510(k) clearance?

FebriDx Bacterial/Non-bacterial Assay received FDA 510(k) clearance on 2026-03-24, under 510(k) number K260787.

Who is the listed applicant for FebriDx Bacterial/Non-bacterial Assay?

The FDA 510(k) record lists Lumos Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FebriDx Bacterial/Non-bacterial Assay?

The FDA product code for FebriDx Bacterial/Non-bacterial Assay is QXA.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07211997FebriDx® Pediatric Validation StudyRECRUITING

Other records listing Lumos Diagnostics, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K230917FebriDx Bacterial / Non-bacterial Point of Care Assay

Related Devices (Code: QXA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K230917FebriDx Bacterial / Non-bacterial Point of Care AssayLumos Diagnostics, Inc.

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.

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