QGN · Class II · 21 CFR 866.3230

FDA Product Code QGN: Lateral Flow Immunochromatography Assay For Host Infection Biomarkers

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.

Leading manufacturers include Cd Diagnostics, Inc..

2
Total
1
Cleared
178d
Avg days
2019
Since
Stable submission activity - 0 submissions in the last 2 years

FDA 510(k) Cleared Lateral Flow Immunochromatography Assay For Host Infection Biomarkers Devices (Product Code QGN)

2 devices
1–2 of 2
Cleared Aug 11, 2021
Synovasure Alpha Defensin Lateral Flow Test Kit (1 Kit), Synovasure Alpha Defensin Lateral Flow Test Kit (5 Test), Synovasure Alpha Defensin Lateral Flow Test Kit (10 Test), Synovasure Alpha Defensin Flow Test Kit (30 Test), Synovasure Alpha Defensin Control Kit
K212204
Cd Diagnostics, Inc.
Microbiology · 27d

About Product Code QGN - Regulatory Context

510(k) Submission Activity

2 total 510(k) submissions under product code QGN since 2019, with 1 receiving FDA clearance (average review time: 178 days).

Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.

QGN devices are reviewed by the Microbiology panel. Browse all Microbiology devices →