|Trade Name||BIO-RAD CYCLOSPORINE BY HPLC TEST|
|Classification Name||high performance liquid chromatography for cyclosporine|
|Generic Name||high performance liquid chromatography|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - other|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Change in manufacturer site of the analytical cartridge from the life science group of bio-rad laboratories located in richmond, ca to the clinical systems division of the diagnostics group of bio-rad laboratories located in hercules, ca. , and changing the vendor of the "clean up" columns for the cyclosporin test by hplc.