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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments

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Document Number CR250765
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Document Parent Analyte Analyte Specialty Complexity Effective Date
HY-VEE, INC., Hy-Vee Ovulation Kit  {Hy-Vee Analog Pregnancy Rapid Test} 
CR250765 K230038 Urine hCG by visual color comparison tests Endocrinology WAIVED 02/06/2026
HY-VEE, INC., Hy-Vee Ovulation Kit  {Hy-Vee Ovulation Rapid Test} 
CR250765 CR250765 Luteinizing hormone (LH) Endocrinology WAIVED 02/06/2026
HY-VEE, INC., Hy-Vee Analog Pregnancy Rapid Test  
CR250765 K230038 Urine hCG by visual color comparison tests Endocrinology WAIVED 02/06/2026
HY-VEE, INC., Hy-Vee Ovulation Rapid Test  
CR250765 CR250765 Luteinizing hormone (LH) Endocrinology WAIVED 02/06/2026

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