|Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.|
|Trade Name||IMX TACROLIMUS II ASSAY|
|Docket Number|| 97M-0520|
|Notice Date|| 01/06/1998|
|Expedited Review Granted?|| Yes|
|Approval Order Statement |
Approval for the imx(r) tacrolimus ii assay. This device is indicated for use as an in-vitro reagent sytemf or the quantitative determination of tacrolimus and some metabolites in human whole blood as an aid in the management of liver allograft patients receiving tacrolimus therapy.
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