Myeloperoxidase, Immunoassay, System, Test
Device Code: 6015
Product Code(s):
NTV 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
Device Classification Information
| Device Type ID | 6015 |
| Device Name | Myeloperoxidase, Immunoassay, System, Test |
| Regulation Description | Low-density Lipoprotein Immunological Test System. |
| Regulation Medical Specialty | Immunology |
| Review Panel | Toxicology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR)
|
| Submission Type | 510(k) |
| CFR Regulation Number | 866.5600 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | NTV |
| 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 | 6015 |
| Device | Myeloperoxidase, Immunoassay, System, Test |
| Product Code | NTV |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Low-density Lipoprotein Immunological Test System. |
| CFR Regulation Number | 866.5600 [🔎] |
TPLC Last Update: 2019-04-02 21:16:05