NTV — Myeloperoxidase, Immunoassay, System, Test Class II
FDA product code NTV covers "Myeloperoxidase, Immunoassay, System, Test", a Class II medical device regulated under 21 CFR 866.5600. Submissions are reviewed by the Immunology panel. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- NTV
- Device Class
- Class II
- Regulation Number
- 866.5600
- Submission Type
- Review Panel
- TX
- Medical Specialty
- Immunology
- Implant
- No
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.