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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments
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Analyte Urine Qualitative Dipstick Leukocytes Complexity waived
 
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Document Analyte Analyte Specialty Effective Date
Henry Schein Urispec 5-Way Plus Reagent Test Strips  
K991927 Urine Qualitative Dipstick Leukocytes Urinalysis 04/16/2013
Moore Medical, mooremedical Urine Analyzer U120  
K070929 Urine Qualitative Dipstick Leukocytes Urinalysis 03/15/2013
Henry Schein URISPEC Urinalysis Reagent Strips  
K970250 Urine Qualitative Dipstick Leukocytes Urinalysis 03/11/2013
Cliawaived Inc. Auto Urinalysis Reagent Strips  
K061559 Urine Qualitative Dipstick Leukocytes Urinalysis 02/22/2013
Henry Schein Urispec Plus Urine Analyzer  
K061742 Urine Qualitative Dipstick Leukocytes Urinalysis 01/29/2013
CLIAwaived Inc. Automated Urinalysis Test System  
K070929 Urine Qualitative Dipstick Leukocytes Urinalysis 01/23/2013
Acon Laboratories, Inc. Insight U120 Urine Analyzer  
K070929 Urine Qualitative Dipstick Leukocytes Urinalysis 09/26/2012
Acon Laboratories, Inc. Insight Urinalysis Reagent Strips (Urine)  
K061559 Urine Qualitative Dipstick Leukocytes Urinalysis 09/26/2012
SCI International Inc. New Choice Urinary Tract Infection (UTI) Test Strips  
K103037 Urine Qualitative Dipstick Leukocytes Urinalysis 09/25/2012
Experian Health, Phinex Urinalysis Reagent Strips  
K061559 Urine Qualitative Dipstick Leukocytes Urinalysis 08/27/2012

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