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  6. BK251286- a) cobas® HIV-1 Quantitative nucleic acid test for use on the cobas® 5800/6800/8800 systems and b) cobas® HIV-1/HIV-2 Qualitative Nucleic acid test for use on the cobas® 5800/6800/8800 systems
  1. Substantially Equivalent 510(k) Device Information

BK251286- a) cobas® HIV-1 Quantitative nucleic acid test for use on the cobas® 5800/6800/8800 systems and b) cobas® HIV-1/HIV-2 Qualitative Nucleic acid test for use on the cobas® 5800/6800/8800 systems

510(k) Number: BK251286
Applicant: Roche Molecular Systems, Inc
Device Name: a) cobas® HIV-1 Quantitative nucleic acid test for use on the cobas® 5800/6800/8800 systems; b) cobas® HIV-1/HIV-2 Qualitative Nucleic acid test for use on the cobas® 5800/6800/8800 systems
Decision Date: 11/21/2025

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