Product code OSX
- Device name
- Galectin-3 In Vitro Diagnostic Assay
- Medical specialty
- Clinical Chemistry
- Device class
- 2
- Regulation number
- 862.1117
- Review panel
- CH
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- 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.
- Source
- FDA openFDA device classification dataset