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.
| Device Type ID | 646 |
| Device Name | Galectin-3 In Vitro Diagnostic Assay |
| Physical State | In Vitro Diagnostic Reagent Kit |
| Technical Method | Enzyme Linked Immunosorbent Assay (ELISA) |
| Target Area | In Vitro Diagnostic For Use With Serum And Plasma |
| Regulation Description | B-type Natriuretic Peptide Test System. |
| Regulation Medical Specialty | Clinical Chemistry |
| Review Panel | Clinical Chemistry |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR)
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| Submission Type | 510(k) |
| CFR Regulation Number | 862.1117 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OSX |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |