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U.S. Department of Health and Human Services

OTC - Over The Counter
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Document NumberCR240206
Test Name Wondfo USA Co, Ltd., Wondfo® PdG Urine Test  
Manufacturer NameGuangzhou Wondfo Biotech Co., Ltd.
Consumer Information Phone Number1(888)444-3657
Test TypePregnanediol Glucuronide
Effective Date05/14/2024
Device NameWondfo® PdG Urine Test
510(K) Exempt NumberCR240206
Device Classification NameImmunoassay, Pregnanediol Glucuronide, Over The Counter
Product CodeQKE
Regulation Number862.1620
Panel Name Toxicology
Applicant
Guangzhou Wondfo Biotech Co., Ltd.
# 8 lizhishan rd. science city
huangpu district
guangzhou,  51066 3
Contactkaiyu xiao
Date Received04/16/2024
Decision Date 05/14/2024
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