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
FDA 510(k) Cleared Lateral Flow Immunochromatography Assay For Host Infection Biomarkers Devices (Product Code QGN)
2 devices
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
Cd Diagnostics, Inc.
Microbiology
27d
Not Cleared
May 23, 2019
Synovasure Alpha Defensin Lateral Flow Test Kit, Synovasure Alpha Defensin Lateral Flow Test Kit (5 Test), Synovasure Alpha Defensin Lateral Flow Test Kit (10 Test), Synovasure Alpha Defensin Lateral Flow Test Kit (30 Test), Synovasure Alpha Defensin Control Kit
Cd Diagnostics, Inc.
Microbiology
328d