Product code QGN— Microbiology
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
- Classification name
- Lateral Flow Immunochromatography Assay For Host Infection Biomarkers
- Device class
- Class 2
- Regulation
- 21 CFR 866.3230
- Advisory panel
- Microbiology
- Total cleared
- 2
- First cleared
- Most recent
Market context for product code QGN
FDA has cleared devices under product code QGN between 2019 and 2021, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2021
- 2019
Top applicants under product code QGN
Recent clearances under product code QGN
- K212204 — 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
- DEN180032 — 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.