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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 203 Results
Document Number K993850
 
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Document Parent Analyte Analyte Specialty Complexity Effective Date
Universal Meditech Inc., DiagnosUS Urinalysis Reagent Strips -10 Parameters  
CR180888 K993850 Urine qualitative dipstick ketone Urinalysis WAIVED 01/23/2019
Universal Meditech Inc., DiagnosUS Urinalysis Reagent Strips -10 Parameters  
CR180888 K993850 Urine qualitative dipstick bilirubin Urinalysis WAIVED 01/23/2019
Universal Meditech Inc., DiagnosUS Urinalysis Reagent Strips -10 Parameters  
CR180888 K993850 Urine qualitative dipstick blood Urinalysis WAIVED 01/23/2019
Universal Meditech Inc., DiagnosUS Urinalysis Reagent Strips -10 Parameters  
CR180888 K993850 Urine qualitative dipstick glucose Urinalysis WAIVED 01/23/2019
Universal Meditech Inc., DiagnosUS Urinalysis Reagent Strips -10 Parameters  
CR180888 K993850 Urine qualitative dipstick leukocytes Urinalysis WAIVED 01/23/2019
Universal Meditech Inc., DiagnosUS Urinalysis Reagent Strips -10 Parameters  
CR180888 K993850 Urine qualitative dipstick nitrite Urinalysis WAIVED 01/23/2019
Universal Meditech Inc., DiagnosUS Urinalysis Reagent Strips -10 Parameters  
CR180888 K993850 Urine qualitative dipstick Ph Urinalysis WAIVED 01/23/2019
Universal Meditech Inc., DiagnosUS Urinalysis Reagent Strips -10 Parameters  
CR180888 K993850 Urine qualitative dipstick protein Urinalysis WAIVED 01/23/2019
Universal Meditech Inc., DiagnosUS Urinalysis Reagent Strips -10 Parameters  
CR180888 K993850 Urine qualitative dipstick urobilinogen Urinalysis WAIVED 01/23/2019
Universal Meditech Inc., DiagnosUS Urinalysis Reagent Strips -10 Parameters  
CR180888 K993850 Urine qualitative dipstick specific gravity Urinalysis WAIVED 01/23/2019

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