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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments

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Document Number CR240738
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Document Parent Analyte Analyte Specialty Complexity Effective Date
Dochek USA INC., Amazewell Early Detection Pregnancy Test Midstream  
CR240738 K240643 Urine hCG by visual color comparison tests Endocrinology WAIVED 12/20/2024
Dochek USA INC., Amazewell Early Detection Pregnancy Test Strip  
CR240738 K240643 Urine hCG by visual color comparison tests Endocrinology WAIVED 12/20/2024

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