FDA Product Code QXA: Lateral Flow Immunochromatography Assay For Host Biomarkers Of Respiratory Infection
A Device To Detect And Measure Non-microbial Analytes To Aid In The Detection And Identification Of Localized Human Infections Is Identified As An In Vitro Device Intended For The Detection And Qualitative Measurement, Quantitative Measurement, Or Both Of One Or More Non-microbial Analytes In Human Clinical Specimens To Aid In The Assessment, Identification, Or Both Of A Localized Microbial Infection When Used In Conjunction With Clinical Signs And Symptoms And Other Clinical And Laboratory Findings.
Leading manufacturers include Lumos Diagnostics, Inc..
FDA 510(k) Cleared Lateral Flow Immunochromatography Assay For Host Biomarkers Of Respiratory Infection Devices (Product Code QXA)
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This page lists all FDA 510(k) submissions for Lateral Flow Immunochromatography Assay For Host Biomarkers Of Respiratory Infection devices (product code QXA). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Microbiology FDA review panel. Browse all Microbiology devices →