OSX · Class II · 21 CFR 862.1117

FDA Product Code OSX: Galectin-3 In Vitro Diagnostic Assay

Galectin-3 Is Indicated For Use In Conjunction With Clinical Evaluation As An Aid In Assessing The Prognosis Of Patients Diagnosed With Chronic Heart Failure.

Leading manufacturers include Fujirebio Diagnostics,Inc..

2
Total
2
Cleared
325d
Avg days
2010
Since

FDA 510(k) Cleared Galectin-3 In Vitro Diagnostic Assay Devices (Product Code OSX)

2 devices
1–2 of 2
Cleared Dec 23, 2014
ARCHITECT GALECTIN-3 Reagent Kit, ARCHITECT GALECTIN-3 CALIBRATORS, ARCHITECT GALECTIN-3 CONTROLS
K140436
Fujirebio Diagnostics,Inc.
Chemistry · 305d

About Product Code OSX - Regulatory Context