| Device |
myeloperoxidase, immunoassay, system, test |
| Regulation Description |
Low-density lipoprotein immunological test system. |
| Definition |
Myeloperoxidase, immunoassay, system, test is intended to measure myeloperoxidase in human plasma, to be used in conjunction with clinical history, ecg and cardiac biomarkers to evaluate patients presenting with chest pain that are at risk for major adverse cardiac events, including myocardial infarction, need for revascularization, or death. |
| Regulation Medical Specialty |
Immunology |
| Review Panel |
Toxicology |
|---|
| Product Code | NTV |
|---|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
866.5600
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
| Third Party Review |
Not Third Party Eligible |
|
|
