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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., Wondfo Early Result Pregnancy Test  
K150022 hCG, Urine 07/08/2022
Wondfo USA Co., Ltd., WellLife COVID-19 Antigen Test  (Anterior Nasal Swabs)
K241317 SARS-CoV-2 03/13/2025
Wondfo USA Co., Ltd., WellLife COVID-19 Antigen Home Test  (Anterior Nasal Swabs)
K241317 SARS-CoV-2 11/07/2024
Wondfo USA Co., Ltd., WELLlife COVID-19 / Influenza A&B Home Test  (Anterior Nasal Swab)
K243256 SARS-CoV-2 and other Respiratory viruses 01/17/2025
Wondfo USA Co., Ltd., WELLlife COVID-19 / Influenza A&B Antigen Test  (Anterior Nasal Swab)
K243256 SARS-CoV-2 and other Respiratory viruses 01/17/2025
Wondfo USA Co., Ltd., WELLlife COVID-19 / Flu A&B Home Test  (Anterior Nasal Swab)
K243256 SARS-CoV-2 and other Respiratory viruses 02/12/2025
Wondfo USA Co., Ltd., SAFElife™ T-Dip Methamphetamine (MET/mAMP) Urine Test Panel  
K202567 Methamphetamines 11/16/2023
Wondfo USA Co., Ltd., SAFElife™ T-Dip Amphetamine (AMP) Urine Test Panel  
K202567 Amphetamines 10/23/2023
Wondfo USA Co., Ltd., SAFElife T-Dip Secobarbital (BAR) Urine Test Panel  
K202567 Secobarbital 10/30/2023
Wondfo USA Co., Ltd., SAFElife T-Dip Oxazepam (BZO) Urine Test Panel  
K202567 Oxazepam 10/30/2023
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