|
Device | ADVIA CENTAUR CP PSA ASSAY |
Generic Name | Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer |
Applicant | SIEMENS HEALTHCARE DIAGNOSTICS 333 CONEY STREET WALPOLE, MA 02032-1516 |
PMA Number | P950021 |
Supplement Number | S007 |
Date Received | 07/22/2005 |
Decision Date | 10/07/2005 |
Product Code |
MTF |
Advisory Committee |
Immunology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR TRANSFER OF THE ASSAY TO A NEW BAYER PLATFORM, THE ADVIA CENTAUR CP SYSTEM. THE ADVIA CENTAUR CP PSA ASSAY IS INTENDED TO QUANTITATIVELY MEASURE PROSTATE-SPECIFIC-ANTIGEN (PSA) IN HUMAN SERUM USING THE ADVIA CENTAUR CP SYSTEM. |