QGN

Lateral Flow Immunochromatography Assay For Host Infection Biomarkers

Product code

QGN

Device name

Lateral Flow Immunochromatography Assay For Host Infection Biomarkers

Device class

Class 2

21 CFR

21 CFR 866.3230

Medical specialty

Microbiology

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

2 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).