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 />
21. LifeSign UniStep Mono Test<br />
(whole blood)<br />
Princeton BioMeditech<br />
Corp.<br />
22. McKesson Medi-lab<br />
Per<strong>for</strong>mance Infectious<br />
Mononucleosis Test<br />
Applied Biotech, Inc.<br />
23. Meridian ImmunoCard STAT<br />
Mono (<strong>for</strong> whole blood)<br />
Applied Biotech, Inc.<br />
86308QW<br />
(cont.)<br />
24. PerMaxim RediScreen<br />
Mononucleosis {Whole<br />
Blood}<br />
ACON Laboratories,<br />
Inc.<br />
Qualitative screening test <strong>for</strong> the presence of heterophile<br />
antibodies in human whole blood, which is used as an aid in the<br />
diagnosis of infectious mononucleosis<br />
25. Polymedco, Inc. Poly stat<br />
Mono<br />
Applied Biotech, Inc.<br />
26. Poly Stat Mono Test {Whole<br />
Blood}<br />
Innovacon, Inc.<br />
27. ProAdvantage by NDC<br />
Infectious Mononucleosis<br />
Test Device (Whole Blood<br />
Only)<br />
Biosite Inc.<br />
28. Quidel Cards O.S. Mono (<strong>for</strong><br />
whole blood)<br />
Quidel Corporation<br />
29. Quidel QuickVue+ Infectious<br />
Mononucleosis (Whole<br />
Blood)<br />
Quidel Corporation<br />
30. RAC Medical Clarity MONO<br />
Mononucleosis Rapid Test<br />
Device {Whole Blood}<br />
ACON Laboratories,<br />
Inc.<br />
31. Remel RIM A.R.C. Mono<br />
Test<br />
Applied Biotech, Inc.<br />
* <strong>New</strong>ly added waived test system 41
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