Device |
prostate-specific antigen (psa) for prognostic, recurrence risk assessment of prostate cancers |
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 Code | OWM |
Regulation Number |
866.6040
|
Device Class |
2
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