Test Classification Current Value
This test was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. This test has not been cleared or approved by the U.S. Food and Drug Administration.
Test Classification Value Prior to 7/31/2014 10:05am
Regulatory Information/Test classification/NY State approval does not need to be entered by the lab in Templates. These fields will be entered into LTC by the system analyst based on the regulatory review memo.