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CLIA Waived Tests for Manufacturers

Clinical Laboratory Improvement Amendment of 1988 (CLIA). The CLIA-waived status allows a broad base of physicians to perform a test at the point-of-care setting.
CPT CODE MEDICARE FEE CAP TEST NAME (SELECTED PRODUCTS/MANUFACTURERS)
87809QW$16.88Adenovirus Test Kit (Rapid Pathogen Screening [RPS])
82055QW$15.21Alcohol Saliva Test (STC Diagnostics, Q.E.D Diagnostics)
85576QW$30.23Aspirin resistance test(VerifyNow Accumetrics)
87905QW$17.2Bacterial Vaginosis Test(Sekisui)
83518QW$11.93Bladder Cancer Antigen (BTA Stat Test, Polymedco)
83880QW$47.77BNP test (Triage BNP Test, Biosite Corp)
Varies$VariesChemistry tests: Albumin, Alkaline Phospha-tase, Amylase, Basic metabolic panel, Comprehensive metabolic panel, GGT, Total Bilirubin, Total Protein (Abaxis Piccolo, i-STAT, Polymedco Spotchem EZ)
82465QW$6.13Cholesterol (Roche, Actimed Labs, Lifestream Technologies)
82044QW$6.44Dipstick Albumin (Roche, Sekisui Diagnostics)
81002$3.6Dipstick/Tablet Urinalysis
81002$3.6Dipstick Urinalysis+Creatinine (Bayer)
81003QW+82570QW$3.16+$7.28Dipstick Urine Analyzer (Bayer, Roche)+Creatinine (Bayer Status Analyzer)
G0434$20.47Drugs of Abuse tests
82272$4.58FOB, Diagnostic (Hemoccult, Beckman Coulter, Seracult Propper)
82270$4.58FOB, Screening
82274QW or G0328$22.38FOB, Immunoassay (Alfa Scientific, Hemoccult ICT Beckman Coulter, Immunostics, Quidel)
83001QW$26.15FSH (BTNX Rapid Response Urine Menopause FSH Test)
82272QW$4.58Gastric Occult Blood (Beckman Coulter)
82962$3.29Glucose Meters
82951QW$18.12Glucose Tolerance Test, 3 Specimens
82947QW$5.52Glucose (HemoCue Glucose 201 Analyzer)
83036QW$13.66Hemoglobin A1c (Siemens Vantage, Cholestech GDX, Bayer A1c Now)
85014QW$3.33Hematocrit (StatSpin)
85018QW$3.33Hemoglobin (HemoCue)
86318QW+86318$18.22H.pylori test whole blood+H. pylori serum/plasma (Quidel, BD, Sekisui )
87338QW$20.24H. pylori test, stool(Meridian Bioscience, Immunocard)
86677$20.42H. pylori, antibody (Sekisui)
86703QW$19.3HIV Rapid Test (OraSure)
87804QW+87804$16.88Influenza Rapid Test Kits (Quidel, Sekisui Diagnostics )
83655QW$17.03LeadCare II Blood Lead Test System (ESA Biosciences, Chelmsford, MA)
80061QW$18.65Lipid Panel (Cholestech, Abaxis)
84460QW$7.44ALT (SGPT)
84450QW$7.28AST (SGOT)
83721QW$13.42LDL (Polymer Technology; Cardiocheck PA)
86618QW$23.97Lyme Disease Rapid Test Kit (Alere)
82043QW$8.14Microalbumin, Urine Quantitative (HemoCue)
82044QW$6.44Microalbumin Immunoassay (Sekisui Diagnostics)
86308QW+86308$7.28Mononucleosis Test Kits (Alere, Quidel, Sekisui Diagnostics)
80101QW$19.72Nicotine Test (NicCheck, Dynagen)
84830$14.12Ovulation Test Kits
81025$8.9Pregnancy Test Kits Urine, Qualitative (Beckman Coulter, Sekisui, Quidel)
84703QW+84703$10.57Pregnancy Test (Quidel, Sekisui Diagnostics)
85610QW$5.53Prothrombin Time (Protime ITC Corp, CoaguChek Roche, Hemosense)
87807QW$16.88RSV Rapid Test Kit (Binax, Integrated Biotechnology, Quidel)
85651$5Sedimentation Rate, Non-Automated
87880QW$16.88Strep Rapid Test Kits (Alere, Beckman Coulter, BD, Quidel, Sekisui Diagnostics)
87808QW+87808$16.88Trichomonas Rapid Test Kit (Sekisui Diagnostics)
84443QW$23.64TSH, qualitative
83518QW$11.93Urinary Albumin (Sekisui Diagnostics)
81007QW$3.61Urinary Tract Infections (Jant Pharmacal)

This list omits certain waived tests that are typically not performed in physician office settings. For a complete listing of every waived test by brand name, go to:

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCLIA/search.cfm