|
Device | ELECSYS TOTAL PSA IMMUNOASSAY |
Generic Name | Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer |
Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. INDIANAPOLIS, IN 46250 |
PMA Number | P990056 |
Supplement Number | S012 |
Date Received | 04/25/2011 |
Decision Date | 05/24/2011 |
Product Code |
MTF |
Advisory Committee |
Immunology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement CHANGE IN MANUFACTURING SITE FROM BUILDINGS 351/352 TO BUILDING 761, ALL WITHIN THE ROCHE PENZBERG, GERMANY FACILITY FOR PRODUCTION OF A COMPONENT (BIOTINYLATED- AND RUTHENIUM-LABELED ANTIBODIES OR CONJUGATED ANTIBODIES) USED IN THIS ASSAY. |