FebriDx Bacterial / Non-bacterial Point of Care Assay
K-Number: K230917 · 2023-06-30
Device Summary
Frequently Asked Questions
What is the FebriDx Bacterial / Non-bacterial Point of Care Assay?
FebriDx Bacterial / Non-bacterial Point of Care Assay is a medical device that received FDA 510(k) clearance on 2023-06-30. The listed applicant is Lumos Diagnostics, Inc.. The 510(k) number is K230917.
When did FebriDx Bacterial / Non-bacterial Point of Care Assay receive FDA 510(k) clearance?
FebriDx Bacterial / Non-bacterial Point of Care Assay received FDA 510(k) clearance on 2023-06-30, under 510(k) number K230917.
Who is the listed applicant for FebriDx Bacterial / Non-bacterial Point of Care 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 Point of Care Assay?
The FDA product code for FebriDx Bacterial / Non-bacterial Point of Care 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.
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.
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.
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.