NTVClass II

Myeloperoxidase, Immunoassay, System, Test

Immunology · 21 CFR 866.5600

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.

MDR events0All time

Recalls1All time

Registered firms1Currently listed

510(k) clearances2All time

Recent MDR events

0 adverse event reports on file

No MDR events on file for this product code.

Event type breakdown

No data available.

Most-reported manufacturers

No data available.

Recalls

1 recall events for this product code

BioCheck Inc
TerminatedMar 11, 2011
Myeloperoxidase (MPO) ELISA kit ;
Product labels indicate that the products are for IVD use and they do not have an approved 510(k).
Z-1642-2011 · View FDA record ↗

Registered firms

1 firms currently registered for this product code

Epitope Diagnostics, Inc.
SAN DIEGO, CA, US

510(k) clearances

2 clearances for this product code