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 />
7. Beckman Coulter Primary<br />
Care Diagnostics Flexsure HP<br />
Test <strong>for</strong> IgG Antibodies to H.<br />
Pylori in Whole Blood<br />
8. Becton Dickinson Link 2 H.<br />
pylori Rapid Test (<strong>for</strong> whole<br />
blood)<br />
9. Cardinal Health SP Brand<br />
Rapid Test H. pylori<br />
(K990892)<br />
10. Cardinal Health SP Brand<br />
Rapid Test H. pylori {Whole<br />
Blood}(K024350/A15)<br />
11. Diagnostic Test Group<br />
Clarity H. pylori Rapid Test<br />
Device {Whole Blood}<br />
12. EarlyDetect H. Pylori Whole<br />
Blood Rapid Test<br />
13. Fisher Healthcare Sure-Vue<br />
H. pylori Test {Whole<br />
Blood}<br />
14. Germaine Laboratories,<br />
Aimstep H. pylori {whole<br />
blood}<br />
15. Henry Schein One Step+ H.<br />
Pylori Rapid Test Device<br />
(Whole Blood)<br />
Beckman Coulter, Inc.<br />
Cortecs Diagnostics<br />
Limited<br />
Applied Biotech Inc.<br />
Innovacon, Inc.<br />
Princeton BioMeditech<br />
Corp.<br />
Alpha Scientific<br />
Designs, Inc.<br />
Innovacon, Inc.<br />
ACON Laboratories,<br />
Inc.<br />
Innovacon, Inc.<br />
* <strong>New</strong>ly added waived test system 43
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