QXA

2 FDA 510(k) clearances · Product code

FDA profile

Official device name

Lateral Flow Immunochromatography Assay For Host Biomarkers Of Respiratory Infection

Device class

Class II (moderate risk)

Regulation

21 CFR 866.3230

Medical specialty

Microbiology

FDA definition

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.

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