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U.S. Department of Health and Human Services

Product Classification

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Device total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
Review Panel Immunology
Product CodeMTF
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
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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