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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 lab-based hiv nat diagnostic and/or supplemental test
510(k) Number BK261349
Tradenames cobas® HIV-1/HIV-2 Qualitative Control Kit for use on the cobas® 5800/6800/8800 systems, cobas® HIV-1/HIV-2 Qualitative Control Kit for use on the cobas® 6800/8800 systems, cobas® HIV-1/HIV-2 Qualitative Nucleic acid test for use on the cobas® 5800/6800/8800 systems, cobas® NHP Negative Control Kit for use on the cobas 5800/6800/8800 systems, cobas® NHP Negative Control Kit for use on the cobas 6800/8800 systems, cobas® Specimen Pre-Extraction Reagent (SPER)
Device Name Human Immunodeficiency Virus (HIV) Nucleic Acid (NAT) Diagnostic And/Or Supplemental Test
Original Applicant
Roche Molecular Systems, Inc.
4300 hacienda drive
pleasanton,  CA  94588
Regulation Number866.3957
Classification Product Code
QST  
Date Received04/03/2026
Decision Date 06/17/2026
Decision substantially equivalent (SE)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
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 No
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