CLIA – New Waived Tests
May 8, 2023Transmittal 11943 – The HCPCS code, effective date and description for the latest tests approved by the FDA as waived tests under CLIA are the following:
- 80305QW, September 16, 2022, Healstone Biotech Inc. Healstone Accurate Drug of Abuse Urine
Test Cup
- 89321QW, December 20, 2022, Medtox Diagnostics Inc. Labcorp OnDemand Men’s Rapid Fertility
Test
- 80305QW, January 4, 2023, Virant Diagnostics Inc. U-Now Drug Test Cup
- 80305QW, January 13, 2023, Sakar International Inc. Vivitar laboratories The Solution Home Rapid
Test Kit/Test Dip Card Multi Drug
- 80305QW, January 13, 2023, Sakar International Inc. Vivitar laboratories The Solution Home Rapid
Test Kit/Multi Test Cup
- 86780QW, G0433QW, February 23, 2023, Chembio Diagnostic Systems, Inc., DPP HIV-Syphilis
(Fingerstick whole blood)