Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

FebriDx Bacterial / Non-bacterial Point of Care Assay

K-Number: K230917 · 2023-06-30

ApplicantLumos Diagnostics, Inc.
Decision Date2023-06-30
Product CodeQXA
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

FebriDx Bacterial / Non-bacterial Point of Care Assay is a medical device manufactured by Lumos Diagnostics, Inc.. It received FDA 510(k) clearance on 2023-06-30 under approval number K230917. 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 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. It is manufactured by Lumos Diagnostics, Inc.. The 510(k) number is K230917.

When was FebriDx Bacterial / Non-bacterial Point of Care Assay approved by the FDA?

FebriDx Bacterial / Non-bacterial Point of Care Assay received FDA 510(k) clearance on 2023-06-30, under approval number K230917.

What company makes FebriDx Bacterial / Non-bacterial Point of Care Assay?

FebriDx Bacterial / Non-bacterial Point of Care Assay is manufactured by Lumos Diagnostics, Inc..

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

NCT07533058 Influence of Finishing Clear Aligner Marginal Termination Design on Subgingival Periodontal Microbiota During Orthodontic Treatment: A Split-Mouth Study. RECRUITING NCT05333679 Urine Tenofovir Point-of-care Test to Identify Patients in Need of ART Adherence Support (UTRA Study) COMPLETED NCT05078853 Thyroglobulin Point of Care Assay for Rapid Detection of Metastatic Differentiated Thyroid Carcinoma COMPLETED NCT07394777 An Open Single-armed Investigation to Evaluate the Safety of pHyph Following a Prolonged Treatment Duration in Adult Women With Bacterial Vaginosis COMPLETED NCT04624880 COMT Activity and Hypnotizability COMPLETED

Other Devices by Lumos Diagnostics, Inc.

K260787FebriDx Bacterial/Non-bacterial Assay

Related Devices (Code: QXA)

K260787FebriDx Bacterial/Non-bacterial 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.

↑