Test Classification

These tests were developed and their performance characteristics determined by The Ohio State University Medical Center Flow Cytometry Lab. They have not been cleared or approved by the FDA. The FDA has determined that such clearance or approval is not required. 

FDA does not require this test to go through pre market FDA review. This test is used for clinical purposes. It should not be regarded as investigational or for research. This laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) as qualified to perform high complexity laboratory testing.