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Lateral Flow Immunochromatography Assay For Host Biomarkers Of Respiratory Infection

FDA product code QXA · 2 cleared devices

Class 2 Microbiology
Regulation
21 CFR 866.3230
Review panel
MI
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2023-06-30 – 2026-03-24

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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