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U.S. Department of Health and Human Services

Product Classification

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Device system, test, her-2/neu, nucleic acid or serum
Review Panel Pathology
Product CodeMVD
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Division of Molecular Genetics and Pathology (DMGP)
Submission Type PMA
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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