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 />
86294QW 1. Bion Diagnostic Sciences<br />
BTA stat Test (<strong>for</strong> home use)<br />
2. Matritech, Inc. NMP22<br />
BladderCheck Test <strong>for</strong><br />
Professional and Prescription<br />
Home Use<br />
86308QW 1. Acceava Mono II {Whole<br />
Blood}<br />
2. Acceava Mono Cassette {For<br />
whole Blood}<br />
3. Acon Mononucleosis Rapid<br />
Test Device {Whole Blood}<br />
4. Acon Mononucleosis Rapid<br />
Test Strip {Whole Blood}<br />
5. Applied Biotech SureStep<br />
Mono Test (whole blood)<br />
6. BioStar Acceava Mono Test<br />
(whole blood)<br />
7. Cardinal Health SP Brand<br />
Rapid Test Mono {Whole<br />
Blood}<br />
8. Clearview MONO Whole<br />
Blood, K042272/A013<br />
Bion Diagnostic<br />
Sciences, Inc.<br />
Maritech, Inc.<br />
Biosite Inc.<br />
Princeton BioMeditech<br />
Corp.<br />
ACON Laboratories,<br />
Inc.<br />
ACON Laboratories,<br />
Inc.<br />
Applied Biotech, Inc.<br />
Wyntek Diagnostics,<br />
Inc.<br />
Cardinal Health<br />
Inverness Medical<br />
Professional<br />
Diagnostics<br />
Immunoassay <strong>for</strong> the qualitative detection of bladder tumor<br />
associated antigen in urine of persons diagnosed with bladder<br />
cancer, and used as an aid in the management of bladder cancer<br />
patients<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 />
* <strong>New</strong>ly added waived test system 39
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