FDA Product Code NTV: Myeloperoxidase, Immunoassay, System, Test
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.
Leading manufacturers include Siemens Healthcare Diagnostics and Prognostix, Inc..
2
Total
2
Cleared
343d
Avg days
2005
Since
FDA 510(k) Cleared Myeloperoxidase, Immunoassay, System, Test Devices (Product Code NTV)
2 devices
Cleared
Dec 10, 2008
DIMENSION CLINICAL CHEMISTRY SYSTEM MPO FLEX REAGENT CARTRIDGE, CALIBRATOR,CONTROL, MODEL RF425, RC425,RC426
Siemens Healthcare Diagnostics
Chemistry
561d
Cleared
May 10, 2005
CARDIOMPO TEST
Prognostix, Inc.
Chemistry
124d