Roche Molecular Systems, Inc. FDA Approvals

0 new drug approvals and 28 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
cobas Strep A Nucleic acid test for use on the cobas Liat System (07341911190); cobas Strep A Quality Control Kit (07402678190)510(k)Aug 28, 2026Microbiology	Microbiology	510(k)Substantially Equivalent (Traditional)	Aug 28, 2026
cobas® Cdiff Nucleic acid test for use on the cobas® Liat® System (07454945190); cobas® Cdiff Positive and Negative Control Kit for use on the cobas® Liat® System (07454970190)510(k)Aug 28, 2026Microbiology	Microbiology	510(k)Substantially Equivalent (Traditional)	Aug 28, 2026
cobas® BV/CV510(k)Jul 16, 2026Microbiology	Microbiology	510(k)Substantially Equivalent (Traditional)	Jul 16, 2026
cobas CT/NG for use on the cobas 5800/6800/8800 systems; cobas TV/MG for use on the cobas 5800/6800/8800 systems510(k)Jul 8, 2026Microbiology	Microbiology	510(k)Substantially Equivalent (Traditional)	Jul 8, 2026
cobas liat CT/NG nucleic acid test510(k)May 15, 2026Microbiology	Microbiology	510(k)Substantially Equivalent (Dual Track)	May 15, 2026
cobas liat CT/NG/MG nucleic acid test510(k)May 15, 2026Microbiology	Microbiology	510(k)Substantially Equivalent (Dual Track)	May 15, 2026
cobas liat Bordetella panel nucleic acid test510(k)Nov 20, 2025Microbiology	Microbiology	510(k)Substantially Equivalent (Dual Track)	Nov 20, 2025
cobas HCV510(k)Nov 3, 2025Microbiology	Microbiology	510(k)Substantially Equivalent (Traditional)	Nov 3, 2025
cobas CMV510(k)Nov 3, 2025Microbiology	Microbiology	510(k)Substantially Equivalent (Traditional)	Nov 3, 2025
cobas Respiratory 4-flex for use on the cobas 5800/6800/8800 Systems510(k)Jul 31, 2025Microbiology	Microbiology	510(k)Substantially Equivalent (Traditional)	Jul 31, 2025
Opulus Lymphoma Precision510(k)May 30, 2025Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	May 30, 2025
cobas liat SARS-CoV-2 & Influenza A/B v2 nucleic acid test510(k)Apr 25, 2025Microbiology	Microbiology	510(k)Substantially Equivalent (Dual Track)	Apr 25, 2025
cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test510(k)Apr 25, 2025Microbiology	Microbiology	510(k)Substantially Equivalent (Dual Track)	Apr 25, 2025
cobas liat SARS-CoV-2 v2 nucleic acid test510(k)Apr 11, 2025Microbiology	Microbiology	510(k)Substantially Equivalent (Dual Track)	Apr 11, 2025
cobas® SARS-CoV-2 Qualitative for use on the cobas® 5800/6800/8800 Systems510(k)Feb 11, 2025Microbiology	Microbiology	510(k)Substantially Equivalent (Traditional)	Feb 11, 2025
cobas® liat CT/NG nucleic acid test510(k)Jan 17, 2025Microbiology	Microbiology	510(k)Substantially Equivalent (Dual Track)	Jan 17, 2025
cobas® liat CT/NG/MG nucleic acid test510(k)Jan 16, 2025Microbiology	Microbiology	510(k)Substantially Equivalent (Dual Track)	Jan 16, 2025
cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System510(k)Dec 4, 2023Microbiology	Microbiology	510(k)Substantially Equivalent (Dual Track)	Dec 4, 2023
cobas® SARS-CoV-2 & Influenza A/B Nucleic acid test for use on the cobas® Liat® System510(k)Jul 27, 2023Microbiology	Microbiology	510(k)Substantially Equivalent (Dual Track)	Jul 27, 2023
cobas SARS-CoV-2 Qualitative for use on the cobas 5800/6800/8800 Systems510(k)Jun 1, 2023Microbiology	Microbiology	510(k)Substantially Equivalent (Special)	Jun 1, 2023
cobas HCV510(k)Nov 4, 2022Microbiology	Microbiology	510(k)Substantially Equivalent (Traditional)	Nov 4, 2022
cobas SARS-CoV-2 Qualitative for use on the cobas 6800/8800 Systems510(k)Oct 22, 2022Microbiology	Microbiology	510(k)Substantially Equivalent (Traditional)	Oct 22, 2022
cobas Influenza A/B & RSV nucleic acid test for use on the cobas Liat System510(k)Jul 6, 2022Microbiology	Microbiology	510(k)Substantially Equivalent (Special)	Jul 6, 2022
cobas Cdiff nucleic acid test for use on the cobas Liat System510(k)Oct 20, 2021Microbiology	Microbiology	510(k)Substantially Equivalent (Special)	Oct 20, 2021
cobas Cdiff nucleic acid test for use on the cobas Liat System510(k)Sep 9, 2021Microbiology	Microbiology	510(k)Substantially Equivalent (Special)	Sep 9, 2021
cobas Influenza A/B & RSV Nucleic acid test for use on the cobas Liat System510(k)Feb 16, 2021Microbiology	Microbiology	510(k)Substantially Equivalent (Special)	Feb 16, 2021
cobas BKV510(k)Jan 29, 2021Microbiology	Microbiology	510(k)Substantially Equivalent (Traditional)	Jan 29, 2021
cobas CTNG for use on cobas 6800/8800 systems510(k)Jan 21, 2021Microbiology	Microbiology	510(k)Substantially Equivalent (Traditional)	Jan 21, 2021

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