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U.S. Department of Health and Human Services

OTC - Over The Counter
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Document NumberCR240395
Test Name Genabio Diagnostics Inc., GenaCheck PdG At-Home Ovulation Confirmation Test  
Manufacturer NameGenabio Diagnostics, Inc.
Consumer Information Phone Number1(800)614-3365
Test TypePregnanediol Glucuronide
Effective Date09/20/2024
Device NameGenaCheck PdG At-Home Ovulation Confirmation Test
510(K) Exempt NumberCR240395
Device Classification NameImmunoassay, Pregnanediol Glucuronide, Over The Counter
Product CodeQKE
Regulation Number862.1620
Panel Name Clinical Chemistry
Applicant
Genabio Diagnostics, Inc.
19 crosby dr. suite 220
bedford,  MA  01730
Contactvivian ruan
Date Received07/12/2024
Decision Date 09/20/2024
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