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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 BK251286
Tradenames cobas® HIV-1 Quantitative nucleic acid test for use on the cobas® 5800/6800/8800 systems, cobas® HIV-1/HIV-2 Qualitative Nucleic acid test for use on the cobas® 5800/6800/8800 systems
Device Name Human Immunodeficiency Virus (Hiv) Viral Load Monitoring Test
Original Applicant
Roche Molecular Systems, Inc.
4300 hacienda drive
pleasanton,  CA  94588
Regulation Number866.3958
Classification Product Code
QUM  
Secondary Product Code
QST 
Date Received09/30/2025
Decision Date 11/21/2025
Decision substantially equivalent (SE)
Classification Advisory Committee Microbiology
Review Advisory Committee Clinical Chemistry
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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