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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments
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Analyte Infectious Mononucleosis Antibodies (Mono) Complexity waived
 
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Document Analyte Analyte Specialty Effective Date
Henry Schein OneStep Pro+ Mono  (Whole Blood)
K961024 Infectious Mononucleosis Antibodies (Mono) General Immunology 03/11/2013
Sekisui Diagnostics, LLC, SIGNIFY MONO TEST  (For whole blood)
K972231 Infectious Mononucleosis Antibodies (Mono) General Immunology 02/16/2012
Consult Diagnostics Mononucleosis Cassette  (Whole Blood)
K961024 Infectious Mononucleosis Antibodies (Mono) General Immunology 10/04/2010
McKesson Medi-Lab Performance Infectious Mononucleosis Test  (For whole blood)
K961024 Infectious Mononucleosis Antibodies (Mono) General Immunology 03/31/2010
Acceava Mono Cassette  (For whole blood)
K961024 Infectious Mononucleosis Antibodies (Mono) General Immunology 01/04/2010
ProAdvantage by NDC Infectious Mononucleosis Test Device (Whole Blood Only)  
K042272 Infectious Mononucleosis Antibodies (Mono) General Immunology 07/16/2009
Acceava Mono II  (Whole Blood)
K042272 Infectious Mononucleosis Antibodies (Mono) General Immunology 04/14/2009
Henry Schein One Step + Mononucleosis Rapid Test Device  (Whole Blood)
K042272 Infectious Mononucleosis Antibodies (Mono) General Immunology 02/26/2008
Clarity MONO Mononucleosis Rapid Test  (Whole Blood)
K961024 Infectious Mononucleosis Antibodies (Mono) General Immunology 02/13/2008
Jant Pharmacal Accutest Value + Mononucleosis Rapid Test  (Whole Blood)
K042272 Infectious Mononucleosis Antibodies (Mono) General Immunology 01/08/2008

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