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Device | SIEMENS IMMULITE PSA AND THIRD GENERATION PSA ASSAYS ON THE IMMULITE, IMMULITE 1000, 2000 AND IMMULITE 2500 ANALYZERS |
Generic Name | Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer |
Applicant | SIEMENS HEALTHCARE DIAGNOSTICS INC. GLYN RHONWY, LLANBERIS GWYNEDD LL55 4EL LL554 |
PMA Number | P930027 |
Supplement Number | S008 |
Date Received | 12/16/2008 |
Decision Date | 02/25/2010 |
Product Code |
MTF |
Advisory Committee |
Immunology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR IMMULITE 1000/2000/2500 PSA AND IMMULITE 1000/2000/2500 THIRD GENERATION PSA TO ADD AN ADDITIONAL ANTIBODY (MURINE MONOCLONAL ANTIBODY CONJUGATE: MAB 7F4), INCLUDE A PH TREATMENT TO THE CHICKEN SERUM AND REMOVAL OF THIMERASOL AS A PRESERVATIVE. |