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Document NumberCR260042
Test Name Vivosens, Inc., vivoo At-Home Vaginal pH Test  
Manufacturer NameGenabio Diagnostics, Inc.
Consumer Information Phone Number1(866)780-6155
Test TypeVaginal pH
Effective Date03/09/2026
Device Namevivoo At-Home Vaginal pH Test
510(K) Exempt NumberCR260042
Device Classification NamePaper, Obstetric Ph
Product CodeLNW
Regulation Number862.1550
Panel Name Clinical Chemistry
Applicant
Genabio Diagnostics, Inc.
19 crosby dr. suite 220
bedford,  MA  01730
Contactchang chen
Date Received01/26/2026
Decision Date 03/09/2026
CLIA Test SystemAnalyteAnalyte SpecialtyComplexityEffective Date
Vivosens, Inc., vivoo At-Home Vaginal pH Test Vaginal pH General Chemistry WAIVED 03/09/2026
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