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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments
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1 to 10 of 18 Results
Document Number K230038
 
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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 Analog Pregnancy Rapid Test  
CR250765 K230038 Urine hCG by visual color comparison tests Endocrinology WAIVED 02/06/2026
Kingsway Pharmaceuticals dba NFI, LLC, SURESIGN Pregnancy Rapid Test  
CR250380 K230038 Urine hCG by visual color comparison tests Endocrinology WAIVED 06/27/2025
RITE AID, RITE AID Pregnancy Test Strips  
CR250030 K230038 Urine hCG by visual color comparison tests Endocrinology WAIVED 03/05/2025
kozekoze LLC, kozekoze Pregnancy Test  
CR250026 K230038 Urine hCG by visual color comparison tests Endocrinology WAIVED 02/24/2025
Medical Group Care, LLC, exchange select Analog Pregnancy Rapid Test  
CR250025 K230038 Urine hCG by visual color comparison tests Endocrinology WAIVED 02/19/2025
Pregmate LLC, Pregmate Pregnancy Test Strip  
CR240490 K230038 Urine hCG by visual color comparison tests Endocrinology WAIVED 09/20/2024
Easy Healthcare Corporation, easy@Home Pregnancy Test (Urine)  
CR240275 K230038 Urine hCG by visual color comparison tests Endocrinology WAIVED 06/04/2024
WALGREEN CO., Walgreens Pregnancy Test Strips  
CR240186 K230038 hCG, Urine Endocrinology WAIVED 05/02/2024
Pregmate LLC, pregmate Pregnancy Midstream Test  
CR240159 K230038 Urine hCG by visual color comparison tests Endocrinology WAIVED 04/10/2024

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