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Device | Sangia Total PSA Test |
Generic Name | Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer |
Applicant | OPKO Diagnostics, LLC. 4 Constitution Way Suite F Woburn, MA 01801 |
PMA Number | P170037 |
Date Received | 11/07/2017 |
Decision Date | 01/30/2019 |
Withdrawal Date
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01/23/2024 |
Product Code |
MTF |
Docket Number | 19M-0505 |
Notice Date | 01/31/2019 |
Advisory Committee |
Immunology |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the Sangia Total PSA Test. The Sangia Total PSA Test is an immunoassay indicated to quantitatively measure total PSA in capillary whole blood from a fingerstick collected by a healthcare professional and is used in conjunction with a digital rectal exam (DRE) as an aid in the detection of prostate cancer in men aged 50 years and older. The Sangia Total PSA Test is performed using the Claros 1 Analyzer in point-of-care settings. A prostate biopsy is required for the diagnosis of prostate cancer. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
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