OSX
- Product code
- OSX
- Device name
- Galectin-3 In Vitro Diagnostic Assay
- Device class
- Class 2
- 21 CFR
- 21 CFR 862.1117
- Medical specialty
- Clinical Chemistry
- Marketing pathway
- 510(K)
- 510(k) clearances (all years, FDA)
- 2 (all years; only the last 3 years are listed here)
FDA classification definition
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.
Official FDA classification page: OSX
Classification and pathway per current FDA publications. Data from openFDA (CC0).