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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 10 Results
Document Number K222305
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HY-VEE, INC., Hy-Vee Digital Pregnancy Rapid Test  
CR250763 K222305 hCG, Urine Endocrinology WAIVED 01/30/2026
Kingsway Pharmaceuticals dba NFI, LLC, SURESIGN Digital Pregnancy Rapid Test  
CR250381 K222305 hCG, Urine Endocrinology WAIVED 06/27/2025
Medical Group Care, LLC, exchange select™ Digital Pregnancy Rapid Test  
CR250022 K222305 hCG, Urine Endocrinology WAIVED 01/29/2025
Wondfo USA Co., Ltd., BABYlife DIGITAL PREGNANCY TEST  
CR240306 K222305 hCG, Urine Endocrinology WAIVED 06/26/2024
Pregmate LLC, pregmate Digital Pregnancy Test  
CR240160 K222305 hCG, Urine Endocrinology WAIVED 04/10/2024
Boston Easy Biotech, Inc., BEB Digital Pregnancy Rapid Test  
CR230767 K222305 hCG, Urine Endocrinology WAIVED 12/06/2023
RITE AID, Digital Pregnancy Rapid Test  
CR230560 K222305 hCG, Urine Endocrinology WAIVED 10/13/2023
Dochek USA Inc., Amazewell Digital Pregnancy Rapid Test  
CR230358 K222305 hCG, Urine Endocrinology WAIVED 07/28/2023
Medical Group Care, LLC, MGC Health Digital Pregnancy Rapid Test  
CR230271 K222305 hCG, Urine Endocrinology WAIVED 06/15/2023
Guangzhou Decheng Biotechnology Co., Ltd., MissLan™ Digital Pregnancy Rapid Test  
CR220274 K222305 hCG, Urine Endocrinology WAIVED 06/07/2023

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