|Trade Name||DIMENSION VISTA FPSA FLEX REAGENT CARTRIDGE|
|Classification Name||test,prostate specific antigen,free,(noncomplexed) to distinguish prostate cancer from benign conditions|
|Generic Name||prostate specific antigen (psa) for detection and management of prostate cancers|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Change the supplier for dextran t110 from sigma adrich fine chemicals (safc) to pharmacomos and to bring phthalocyanine manufacture in-house at the siemens healthcare diagnostics, newark, delaware site and the scale-up of the sensibead concentrate production from 150g per lot size to 300g.