Attachment 2. Extract from the Clinical Evaluation Report ...

In order to isolate free digoxin, serum and urine samples were filtered using a Centrifree micropartition device (Amicon, Inc. Beverly, MA). Free digoxin was then quantified using the OnLine Test Kit for Digoxin (Roche Diagnostic Systems, Somerville, NJ) on a Roche Cobas FARA Instrument. This test is a homogeneous, competitive binding immunoassay. ................
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