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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments

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Analyte Nitrite, urine Complexity waived Effective Date To 12/19/2014
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Well at Walgreens Urinary Tract Infection Test Strips  
CR140409 K063295 Nitrite, urine General Chemistry 11/24/2014
Global Quality Health Inc. UT-Fem For Women UTI Test Strips  
K063295   Nitrite, urine General Chemistry 07/12/2013
Mediwatch Urinewatch UTI Urinary Tract Infection Test Strips  
K063295   Nitrite, urine General Chemistry 09/15/2011
Saless Enterprises, Inc. New Choice Urinary Tract Infection Test Strips  
K063295   Nitrite, urine General Chemistry 06/14/2010
Amerifit Inc Azo Test Strips Urinary Tract Infection Test  
K063295   Nitrite, urine General Chemistry 03/16/2009
Acon Laboratories Mission UTI Urinary Tract Infection Test Strips  
K063295   Nitrite, urine General Chemistry 08/18/2008
AZO Test Strips Urinary Tract Infection Test  
K063295   Nitrite, urine General Chemistry 06/25/2008
ACON Laboratories UTI Urinary Tract Infection Test Strips  
K063295   Nitrite, urine General Chemistry 10/15/2007

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