New Waived Tests - Centers for Medicare & Medicaid Services
New Waived Tests - Centers for Medicare & Medicaid Services
New Waived Tests - Centers for Medicare & Medicaid Services
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TESTS GRANTED WAIVED STATUS UNDER CLIA<br />
CPT CODE(S) TEST NAME MANUFACTURER USE<br />
83880QW<br />
1. Biosite Triage Meter {Whole<br />
Blood}<br />
2. Biosite Triage Meter Plus<br />
{Whole Blood}<br />
Biosite Incorporated<br />
Quantitative measurement of B-type natriuretic peptide (BNP)<br />
83986QW<br />
All qualitative color comparison<br />
pH testing - body fluids (other<br />
than blood)<br />
Various<br />
pH detection (acid-base balance) in body fluids such as semen,<br />
amniotic fluid, and gastric aspirates<br />
83986QW 1. FemTek pHEM-ALERT FemTek, LLC Vaginal pH detection (acid-base balance)<br />
84295QW,<br />
84132QW,<br />
85014QW<br />
84443QW<br />
2. Common Sense Ltd. Norma-<br />
Sense Vaginal Discharge pH<br />
Test<br />
3. Common Sense Ltd. VA-<br />
Sense Kit<br />
4. Common Sense Ltd. VS-<br />
Sense Test {qualitative}<br />
5. Lil’ Drug Store Products Inc.<br />
Vagi-Screen Vaginal Health<br />
Test<br />
Abbott i-STAT E3+ Cartridge<br />
{Whole Blood}<br />
1. Aventir Biotech LLC, Forsure<br />
TSH Test {Whole Blood}<br />
2. BTNX, Inc Rapid Response<br />
Thyroid Stimulating<br />
Hormone (TSH) Test<br />
Cassette<br />
Common Sense Ltd.<br />
Common Sense, Ltd.<br />
Common Sense, Ltd<br />
Lil’ Drug Store<br />
Products Inc.<br />
i-Stat Corporation<br />
Screening Devices<br />
Canada Inc.<br />
Screening Devices<br />
Canada Inc.<br />
Measures potassium, sodium, and hematocrit in whole blood<br />
Qualitative determination of human thyroid stimulating<br />
hormone (TSH) in whole blood, which is a rapid TSH assay <strong>for</strong><br />
hypothyroidism screening in adults<br />
* <strong>New</strong>ly added waived test system 35
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