NTV
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Myeloperoxidase, Immunoassay, System, Test
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5600
- Medical specialty
- Immunology
- Flags
- Third-party review eligible
- FDA 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.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| DIMENSION CLINICAL CHEMISTRY SYSTEM MPO FLEX REAGENT CARTRIDGE, CALIBRATOR,CONTROL, MODEL RF425, RC425,RC426 (K071474) | Siemens Healthcare Diagnostics | 2008-12-10 |
| CARDIOMPO TEST (K050029) | Prognostix, Inc. | 2005-05-10 |
Track NTV automatically
Every clearance here is in the API, with alerts when new ones post.