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U.S. Department of Health and Human Services

Product Classification
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Device test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
Review Panel Immunology
Product CodeMTG
Premarket Review Office of In Vitro Diagnostics (OHT7)
Division of Immunology and Hematology Devices (DIHD)
Submission Type PMA
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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