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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device prostate-specific antigen (psa) for prognostic, recurrence risk assessment of prostate cancers
Regulation Description Gene expression profiling test system for breast cancer prognosis.
Definition Determines rate of increase of total prostate specific antigen at ultrasensitive concentration levels (picogram/ml serum), and identifies those patients following prostatectomies which are at reduced risk for recurrence of prostate cancer.
Product CodeOWM
Regulation Number 866.6040
Device Class 2

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