Regulatory Compliance Definitions

 

FDA Approved

This assay is approved by the U.S. Food and Drug Administration. Its performance characteristics have been verified by the Wisconsin State Laboratory of Hygiene, a Clinical Laboratory Improvement Amendments (CLIA) certified, high complexity clinical laboratory.

 

Emergency Use Authorization (EUA)

This assay has emergency use authorization (EUA) through the U.S. Food and Drug Administration. Its performance characteristics were determined by the Wisconsin State Laboratory of Hygiene, a Clinical Laboratory Improvement Amendments (CLIA) certified, high complexity clinical laboratory.

 

Lab Developed Test (LDT)

This test was developed and its performance characteristics determined by the Wisconsin State Laboratory of Hygiene, a Clinical Laboratory Improvement Amendments (CLIA) certified, high complexity clinical laboratory. It has not been cleared or approved by the U.S. Food and Drug Administration. It was marketed for use prior to May 6th, 2024.

 

Lab Developed Test – Modified FDA Approved

This test was modified from an FDA approved assay and its performance characteristics determined by the Wisconsin State Laboratory of Hygiene, a Clinical Laboratory Improvement Amendments (CLIA) certified, high complexity clinical laboratory. It has not been cleared or approved by the U.S. Food and Drug Administration. It was marketed for use prior to May 6th, 2024.

 

Lab Developed Test – CDC Developed

This test was developed by the CDC and its performance characteristics were determined by the Wisconsin State Laboratory of Hygiene, a Clinical Laboratory Improvement Amendments (CLIA) certified, high complexity clinical laboratory. It has not been cleared or approved by the U.S. Food and Drug Administration. It was marketed for use prior to May 6th, 2024.