The therapeutic range listed relates to the antidepressant characteristics of the drug. A therapeutic range for treating obsessive compulsive disorder is not well established. Toxic concentrations may cause anticholinergic effects, CNS depression, cardiac abnormalities, seizures and hypotension.
Statement B: Compliance Statement B
: For laboratory developed tests not using a RUO kit, and for FDA approved, cleared or 510(k) exempt assays with alterations.
This test was developed and its performance characteristics determined by ARUP Laboratories. The U. S. Food and Drug Administration has not approved or cleared this test; however, FDA clearance or approval is not currently required for clinical use. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions.