Device |
st2 assay |
Regulation Description |
B-type natriuretic peptide test system. |
Definition |
Immunoassay for the in vitro quantitative determination of soluble ST2 protein in human serum and plasma. |
Physical State |
test reagents |
Technical Method |
Quantitative sandwich monoclonal ELISA |
Target Area |
In Vitro Diagnostics |
Regulation Medical Specialty |
Clinical Chemistry |
Review Panel |
Clinical Chemistry |
Product Code | OYG |
Premarket Review |
Office of In Vitro Diagnostics
(OHT7)
Division of Chemistry and Toxicology Devices
(DCTD)
|
Submission Type |
510(k)
|
Regulation Number |
862.1117
|
Device Class |
2
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Eligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Third Party Review |
Not Third Party Eligible |