OYG
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- St2 Assay
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1117
- Medical specialty
- Clinical Chemistry
- FDA definition
- Immunoassay for the in vitro quantitative determination of soluble ST2 protein in human serum and plasma.
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| Record | Firm | Date |
|---|---|---|
| PRESAGE ST2 ASSAY (K111452) | Critical Care Diagnostics, Inc. (Dba Critical Diag | 2011-12-09 |
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