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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments
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1 to 8 of 8 Results
Document Number K252607
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2San LLC, 2San UTI Test  
CR250724 K252607 Urine qualitative dipstick nitrite Urinalysis WAIVED 01/30/2026
2San LLC, 2San UTI Test  
CR250724 K252607 Leukocyte esterase, urinary Urinalysis WAIVED 01/30/2026
Medical Distribution Group Inc., Identify Health Urinary Tract Infection Test  
CR250743 K252607 Urine qualitative dipstick nitrite Urinalysis WAIVED 01/26/2026
Medical Distribution Group Inc., Identify Health Urinary Tract Infection Test  
CR250743 K252607 Leukocyte esterase, urinary Urinalysis WAIVED 01/26/2026
Mobilab Medical Innovatives Inc, Mobilab Urinary Tract Infection Test  
CR250739 K252607 Urine qualitative dipstick nitrite Urinalysis WAIVED 01/26/2026
Mobilab Medical Innovatives Inc, Mobilab Urinary Tract Infection Test  
CR250739 K252607 Leukocyte esterase, urinary Urinalysis WAIVED 01/26/2026
Hangzhou AllTest Biotech Co., Ltd., AllTest Urinary Tract Infection Test  
CR250523 K252607 Urine qualitative dipstick nitrite Urinalysis WAIVED 11/04/2025
Hangzhou AllTest Biotech Co., Ltd., AllTest Urinary Tract Infection Test  
CR250523 K252607 Leukocyte esterase, urinary Urinalysis WAIVED 11/04/2025

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