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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments
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1 to 9 of 9 Results
Document Number K234152
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Document Parent Analyte Analyte Specialty Complexity Effective Date
Aceso Laboratories, Inc., Atida Early Pregnancy Test  
CR250768 K234152 hCG, Urine Endocrinology WAIVED 02/06/2026
Link Logistics Inc., getTested Early Pregnancy Test  
CR250145 K234152 hCG, Urine Endocrinology WAIVED 04/22/2025
Home Health US Inc., One Step hCG Early Rapid Pregnancy Test Midstream  
CR250029 K234152 hCG, Urine Endocrinology WAIVED 02/10/2025
Medical Distribution Group Inc., Identify Health hCG Early Pregnancy Rapid Test  
CR240780 K234152 hCG, Urine Endocrinology WAIVED 01/21/2025
ABOUND Diagnostics, Inc., CHOSEN hCG Early Pregnancy Urine Rapid Test Midstream  
CR240273 K234152 Urine hCG by visual color comparison tests Endocrinology WAIVED 06/11/2024
CITEST DIAGNOSTICS INC, Citest Early Pregnancy Home Test  
CR240199 K234152 hCG, Urine Endocrinology WAIVED 05/09/2024
ACRO BIOTECH, Inc., ACRO Early Pregnancy Rapid Test  
CR240197 K234152 hCG, Urine Endocrinology WAIVED 05/09/2024
Hangzhou AllTest Biotech Co., Ltd., ALLTEST hCG Early Pregnancy Rapid Test  
CR240198 K234152 hCG, Urine Endocrinology WAIVED 05/03/2024
Aceso Laboratories, Inc., ACESO Early Pregnancy Test  
CR230880 K234152 hCG, Urine Endocrinology WAIVED 04/12/2024

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