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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments
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Document Number CR250523
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Document Parent Analyte Analyte Specialty Complexity Effective Date
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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