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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 human immunodeficiency virus (hiv) viral load monitoring test
510(k) Number BK251234
Tradenames Alinity m HIV-1 AMP Kit, Alinity m HIV-1 Application Specification File, Alinity m HIV-1 CAL Kit, Alinity m HIV-1 CTRL Kit
Device Name Human Immunodeficiency Virus (Hiv) Viral Load Monitoring Test
Original Applicant
Abbott Molecular
1300 e touhy ave
des plaines,  IL  60018
Regulation Number866.3958
Classification Product Code
QUM  
Secondary Product Code
QST 
Date Received06/03/2025
Decision Date 08/27/2025
Decision substantially equivalent (SE)
Classification Advisory Committee Microbiology
Review Advisory Committee Clinical Chemistry
Type 510(k) Traditional
Total Product Life Cycle (TPLC) TPLC Device Report
Reviewed by Third Party No
Expedited Review No
Combination Product No
In Vitro Product Yes
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