|Trade Name||DIMENSION VISTA TPSA FLEX REAGENT CARTRIDGE|
|Classification Name||total,prostate specific antigen(noncomplexed&complexed) for detection of prostate cancer|
|Applicant||SIEMENS HEALTHCARE DIAGNOSTICS INC.|
|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.