QGN — Lateral Flow Immunochromatography Assay For Host Infection Biomarkers Class II
FDA product code QGN covers "Lateral Flow Immunochromatography Assay For Host Infection Biomarkers", a Class II medical device regulated under 21 CFR 866.3230. Submissions are reviewed by the Microbiology panel. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- QGN
- Device Class
- Class II
- Regulation Number
- 866.3230
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
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.