New Waived Tests effective October 1, 2014

Listed below are the latest tests approved by the FDA as waived tests under CLIA. CPT codes for the following new tests must have the modifier QW to be recognized as a waived test.

• G0434QW, September 6, 2013, BTNX Inc. Rapid Response Multi-Drug Urine Test Cup;

• G0434QW, September 6, 2013, BTNX Inc. Rapid Response Multi-Drug Urine Test Panel;
• G0434QW, October 4, 2013, uVera Diagnostics, Inc. CR2 Multi-Drug Urine Test Cup;
• G0434QW, October 4, 2013, uVera Diagnostics, Inc. CR3 Multi-Drug Urine Test Cup;
• G0434QW, October 4, 2013, uVera Diagnostics, Inc. SMARTOX U3 Multi-Drug Urine Test Cup;
• G0434QW, October 24, 2013, American Institute of Toxicology, Inc., AIT Laboratories Drug of Abuse Cup;

• 80061QW, 82962, 82465QW, 83718QW, 84478QW, November 12, 2013, Jant Pharmacal LipidPlus Lipid Profile and Glucose Measuring System (LipidPlus  Lipid Profile test strips);

• G0434QW, December 4, 2013, Nobel Medical Inc. INSTA-SCREEN Multi-Drug Urine Test Cup;
• G0434QW, December 5, 2013, Micro Distributing II, LTD One Step Multi-Drug Urine Test Panel;
• G0434QW, February 11, 2014, Alfa Scientific Designs, Inc. Confidential Drug Test – Multi Drugs of Abuse Urine Test (OTC);
• 87880QW, February 18, 2014, BD Veritor System for Rapid Detection of Group A Strep (direct from throat swab);

• 85018QW, February 18, 2014, Clarity HbCheck Hemoglobin Testing System;

• 87077QW, February 18, 2014, Jant Accutest Rapid Urease test (H. pylori detection);
• G0434QW, March 13, 2014, UCP Biosciences, Inc. UCP Multi-Drug Test Key Cups;
• 83986QW, March 18, 2014, RightBio Metrics, RightSpot Infant pH Indicator;
• 83986QW, March 18, 2014, RightBio Metrics, RightSpot pH Detector;
• 83986QW, March 18, 2014, RightBio Metrics, RightSpot pH Indicator;
• 85018QW, March 21,2014, AimStrip Hb Hemoglobin (Hb) Testing System;
• G0434QW, April 11, 2014, PTox Drug Screen Cup {Cassette Dip Card format};
• 86308QW, April 22, 2014, Polymedco Polystat Mono {whole blood};
• 82274QW, G0328QW, April 22, 2014, Rapid Response(TM) FIT-Fecal Immunochemical Test;

• 84443QW, May 16, 2014, Germaine Laboratories, Inc. AimStep Thyroid Screen {whole blood};

• 82055QW, May 21, 2014, Express Diagnostics International, Incorporated Saliva Alcohol Test;
• 83037QW, May 22, 2014, BIO-RAD in2it (II) System Analyzer Prescription Home Use; and
• 87880QW, May 23, 2014, Accustrip Strep A {Specimen type (Throat Swab)}.

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