Galectin-3 In Vitro Diagnostic Assay

FDA product code OSX · Class II (moderate risk) · 21 CFR 862.1117 · Clinical Chemistry

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.

2510(k) clearances
0PMA approvals
0recalls

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K140436ARCHITECT GALECTIN-3 Reagent Kit, ARCHITECT GALECTIN-3 CALIBRATORS, ARCHITECT GALECTIN-3…OSX · Traditional Fujirebio Diagnostics,Inc.12/23/2014SE
K093758BGM Galectin -3OSX · Traditional Bg Medicine, Inc.11/17/2010SE