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  1. Substantially Equivalent 510(k) Device Information

BK261349- cobas® HIV-1/HIV-2 Qualitative nucleic acid test for use on the cobas® 5800/6800/8800 systems

510(k) Number: BK261349
Applicant: Roche Molecular Systems, Inc.
Device Name: cobas® HIV-1/HIV-2 Qualitative nucleic acid test for use on the cobas® 5800/6800/8800 systems
Decision Date: 06/17/2026

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