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U.S. Department of Health and Human Services

510(k) Premarket Notification
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New Search Biologics Clearance Letters and 510(k) Summaries Back To Search Results
Device Classification Name point of care hiv serology diagnostic and/or supplemental test
510(k) Number BK251254
Tradename Geenius HIV 1/2 Supplemental Assay
Device Name Human Immunodeficiency Virus (HIV) serological diagnostic and/or supplemental test
Original Applicant
Bio-Rad Laboratories, Inc.
14620 ne north woodinville way
woodinville,  WA  98072
Regulation Number866.3956
Classification Product Code
QSU  
Date Received07/29/2025
Decision Date 08/26/2025
Decision substantially equivalent (SE)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
Type 510(k) Special
Total Product Life Cycle (TPLC) TPLC Device Report
Reviewed by Third Party No
Expedited Review No
Combination Product No
In Vitro Product No
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