Listed below are the latest tests approved by the Food and Drug Administration (FDA) as waived tests under CLIA (Clinical Laboratory Improvement Amendments of 1988).
The CPT code, effective date and description for the latest tests approved by the FDA as waived tests under CLIA are as follows:
- 82010QW, 82962, May 27, 2022, AmVentureX Inc. BioCoach Blood Glucose and Ketone Monitoring System;
- 80305QW, June 07, 2022, Micro Distributing STATDIP One Step Drug Test;
- 80305QW, June 07, 2022, Micro Distributing STATCup II One Step Drug Test Cup;
- 87880QW, June 09, 2022, Clarity Diagnostics LLC Clarity Strep A Rapid Test Strip;