New Waived Tests – MLN Matters Number: MM12581
February 7, 2022The HCPCS code, effective date, and description for the latest tests approved by the FDA as waived tests under CLIA are the following:
September 23, 2021
- 81003QW, Teco Diagnostics Inc. Uritek TC-201 Urine Chemistry Test System
October 7, 2021
- 87880QW, Cardinal Health Strep A Dipstick – Rapid Test
October 20, 2021
- 80048QW, Abaxis Piccolo Blood Chemistry Analyzer {Piccolo Basic Metabolic Panel Reagent Disc} (Whole Blood)
- 80053QW, Abaxis Piccolo Blood Chemistry Analyzer {Piccolo Comprehensive Metabolic Panel Reagent Disc} (Whole Blood)
- 80051QW, Abaxis Piccolo Blood Chemistry Analyzer {Piccolo Electrolyte Panel Reagent Disc} (Whole Blood)
- 82374QW, 82435QW, 82550QW, 82565QW, 82947QW, 84132QW, 84295QW and 84520QW, Abaxis Piccolo Blood Chemistry Analyzer {Piccolo Metlyte 8 Panel Reagent Disc} (Whole Blood)
- 80069QW, Abaxis Piccolo Blood Chemistry Analyzer {Piccolo Renal Function Panel Reagent Disc} (Whole Blood)
- 80048QW, Abaxis Piccolo xpress Chemistry Analyzer {Piccolo Basic Metabolic Panel Reagent Disc} (Whole Blood)
- 80053QW, Abaxis Piccolo xpress Chemistry Analyzer {Piccolo Comprehensive Metabolic Panel Reagent Disc} (Whole Blood)
- 80051QW, Abaxis Piccolo xpress Chemistry Analyzer {Piccolo Electrolyte Panel Reagent Disc} (Whole Blood)
- 82374QW, 82435QW, 82550QW, 82565QW, 82947QW, 84132QW, 84295QW and 84520QW, Abaxis Piccolo xpress Chemistry Analyzer {Piccolo Metlyte 8 Panel Reagent Disc} (Whole Blood)
- 80069QW, Abaxis Piccolo xpress Chemistry Analyzer {Piccolo Renal Function Panel Reagent Disc} (Whole Blood)
November 10, 2021
- 87880QW, Cardinal Health H. Pylori Rapid Test – Whole Blood/Serum Cassette (Whole Blood)
CR Transmittal Number: R11188CP
Source: https://www.cms.gov/files/document/mm12581-new-waived-tests.pdf