NTV · Class II — Moderate Risk (510(k) clearance required) · Immunology · 21 CFR 866.5600
Classification
FDA Product Code
NTV
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 866.5600
Review panel
TX
Medical specialty
Immunology
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
Y
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.