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U.S. Department of Health and Human Services

OTC - Over The Counter

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500 records meeting your search criteria returned . please narrow your search.
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Test Name
Document Test Type Effective Date
Wondfo USA Co., Ltd., Preview Fertility Combination Tests  {Preview Pregnancy Test Strip} 
K043443 Urine hCG by visual color comparison tests 08/19/2020
Wondfo USA Co., Ltd., Preview Fertility Combination Tests  {Preview Ovulation Test Strip} 
CR200366 Luteinizing hormone (LH) 08/19/2020
Wondfo USA Co., Ltd., HORMONElife Ultra Accurate Ovulation Test Strip  
CR250101 Luteinizing hormone (LH) 04/08/2025
Wondfo USA Co., Ltd., HORMONElife Ultra Accurate FSH Test Strip  
CR240759 Follicle stimulating hormone (FSH) 01/13/2025
Wondfo USA Co., Ltd., HORMONElife Pregnancy Test Strip  
K043443 Urine hCG by visual color comparison tests 04/07/2025
Wondfo USA Co., Ltd., HORMONElife Pregnancy Home Test Midstream  
K043443 Urine hCG by visual color comparison tests 05/02/2025
Wondfo USA Co., Ltd., HORMONElife Pregnancy Home Test Cassette  
K043443 Urine hCG by visual color comparison tests 12/19/2025
Wondfo USA Co., Ltd., HORMONElife PdG Urine Test Strip  
CR250085 Pregnanediol Glucuronide 04/07/2025
Wondfo USA Co., Ltd., HORMONElife Ovulation Test Strip  
CR250084 Ovulation test (LH) By visual color comparison 04/03/2025
Wondfo USA Co., Ltd., HORMONElife Fertility Combination Tests  {HORMONElife Ovulation Test Strip} 
CR250599 Luteinizing hormone (LH) 10/28/2025
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