Lateral Flow Immunochromatography Assay For Host Infection Biomarkers
QGN · Class II — Moderate Risk (510(k) clearance required) · Microbiology · 21 CFR 866.3230
Classification
FDA Product Code
QGN
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 866.3230
Review panel
MI
Medical specialty
Microbiology
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.