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U.S. Department of Health and Human Services

OTC - Over The Counter
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Document NumberCR260448
Test Name Diagnox LLC, PdG Test  
Manufacturer NameGuangzhou Wondfo Biotech Co., Ltd.
Consumer Information Phone Number1(866)342-4669
Test TypePregnanediol Glucuronide
Effective Date08/10/2026
Device NamePdG Test
510(K) Exempt NumberCR260448
Device Classification NameImmunoassay, Pregnanediol Glucuronide, Over The Counter
Product CodeQKE
Regulation Number862.1620
Panel Name Clinical Chemistry
Applicant
Guangzhou Wondfo Biotech Co., Ltd.
# 8 lizhishan rd., science cit
huangpu district
guangzhou,  51066 3
Contactkaiyu xiao
Date Received06/10/2026
Decision Date 08/10/2026
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