Imx Tacrolimus II Assay

FDA premarket approval P970007 · Enzyme Immunoassay, Tracrolimus

PMA numberP970007

Approval

Applicant
Abbott Laboratories
Received
February 18, 1997
Decision date
August 26, 1997 (APRL)
Supplements
4, latest September 5, 2002
Product code
MLM – Enzyme Immunoassay, Tracrolimus

Official FDA PMA record

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.