QGN

2 FDA 510(k) clearances · Product code

FDA profile

Official device name: Lateral Flow Immunochromatography Assay For Host Infection Biomarkers
Device class: Class II (moderate risk)
Regulation: 21 CFR 866.3230
Medical specialty: Microbiology
FDA 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.

Record	Firm	Date
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.	2021-08-11
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 (DEN180032)	Cd Diagnostics, Inc.	2019-05-23

Every clearance here is in the API, with alerts when new ones post.