OSX
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Galectin-3 In Vitro Diagnostic Assay
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1117
- Medical specialty
- Clinical Chemistry
- FDA 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.
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| Record | Firm | Date |
|---|---|---|
| ARCHITECT GALECTIN-3 Reagent Kit, ARCHITECT GALECTIN-3 CALIBRATORS, ARCHITECT GALECTIN-3 CONTROLS (K140436) | Fujirebio Diagnostics,Inc. | 2014-12-23 |
| BGM GALECTIN -3 (K093758) | Bg Medicine, Inc. | 2010-11-17 |
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Every clearance here is in the API, with alerts when new ones post.