St2 Assay
Device Code: 650
Product Code(s):
OYG Definition: Immunoassay For The In Vitro Quantitative Determination Of Soluble ST2 Protein In Human Serum And Plasma.
Device Classification Information
| Device Type ID | 650 |
| Device Name | St2 Assay |
| Physical State | Test Reagents |
| Technical Method | Quantitative Sandwich Monoclonal ELISA |
| Target Area | In Vitro Diagnostics |
| 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)
|
| Submission Type | 510(k) |
| CFR Regulation Number | 862.1117 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OYG |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
Recognized Standards
Total Product Life Cycle
| Device Type ID | 650 |
| Device | St2 Assay |
| Product Code | OYG |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | B-type Natriuretic Peptide Test System. |
| CFR Regulation Number | 862.1117 [🔎] |
TPLC Last Update: 2019-04-02 19:38:06