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U.S. Department of Health and Human Services

Product Classification
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Device prostrate cancer genes nucleic acid amplification test system
Definition An in vitro nucleic acid amplification test that measures the concentration of prostate cancer genes.
Physical State Capture oligonucleotides, magnetic microparticles, transcription-based nucleic acid amplification reagents, chemiluminescent-labeled nucleic acid probes. luminometer, software
Technical Method Utilizes nucleic acid probes and/or primers along with other reagents to detect prostrate cancer genes RNA from human specimens.
Target Area Currently this type of device is only utilized on urine specimens, but other specimen types may be possible.
Review Panel Immunology
Product CodeOYM
Premarket Review Division of Immunology and Hematology Devices (DIHD)
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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