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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 Effective Date To 11/24/2014
 
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Document Parent Analyte Analyte Specialty Effective Date
AimStep Mono  (Whole Blood)
CR140342 K961024 Infectious mononucleosis antibodies (mono) General Immunology 09/23/2014
QUIDEL QUICKVUE+ MONONUCLEOSIS  (Whole Blood)
CR140229 K902510 Infectious mononucleosis antibodies (mono) General Immunology 07/11/2014
Jant Pharmacal Corp. Accutest Rapid Mono Test  (Whole Blood)
CR140211 K961024 Infectious mononucleosis antibodies (mono) General Immunology 07/07/2014
Polymedco Polystat Mono  (Whole Blood)
K961024   Infectious mononucleosis antibodies (mono) General Immunology 04/22/2014
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

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