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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments

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1 to 10 of 57 Results
Analyte Infectious Mononucleosis Antibodies (Mono) Complexity waived Effective Date To 04/18/2014
 
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Document Parent Analyte Analyte Specialty Effective Date
DE HEALTHCARE PRODUCTS TRUVIEW MONO TEST  
K973559   Infectious mononucleosis antibodies (mono) General Immunology 09/10/2013
Clarity MONO Mononucleosis Rapid Test Device (whole blood)  
K042272   Infectious mononucleosis antibodies (mono) General Immunology 09/10/2013
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)
K043385   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

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