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U.S. Department of Health and Human Services

Product Classification

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Device myeloperoxidase, immunoassay, system, test
Regulation Description Low-density lipoprotein immunological test system.
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.
Regulation Medical Specialty Immunology
Review Panel Toxicology
Product CodeNTV
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 866.5600
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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