cobas SARS-CoV-2 Qualitative for use on the cobas 5800/6800/8800 Systems— 510(k) K231306
Substantially EquivalentRoche Molecular Systems, Inc.
FDA 510(k) clearance K231306 for cobas SARS-CoV-2 Qualitative for use on the cobas 5800/6800/8800 Systems, Substantially Equivalent on 2023-06-01. Applicant: Roche Molecular Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Roche Molecular Systems, Inc.
- Product code
- Code QQX
- Device class
- Class 2
- Regulation
- 21 CFR 866.3981
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Pleasanton, CA, US
Recent devices under product code QQX
view all- K243396 — Aptima SARS-CoV-2 Assay
- K240867 — cobas® SARS-CoV-2 Qualitative for use on the cobas® 5800/6800/8800 Systems
- K242109 — Xpert® Xpress CoV-2 plus (XPRS-COV2-10)
- K241580 — Alinity m SARS-CoV-2 AMP Kit (09N78-096); Alinity m SARS-CoV-2 CTRL Kit (09N78-086)
- K233453 — Applied Biosystems TaqPath COVID-19 Diagnostic PCR Kit
More clearances from Roche Molecular Systems, Inc.
view all- K260045 — cobas® Cdiff Nucleic acid test for use on the cobas® Liat® System (07454945190) +1 more
- K260047 — cobas Strep A Nucleic acid test for use on the cobas Liat System (07341911190) +1 more
- K260021 — cobas® BV/CV
- K260917 — cobas CT/NG for use on the cobas 5800/6800/8800 systems; cobas TV/MG for use on the cobas 5800/6800/8800 systems
- K253756 — cobas liat CT/NG nucleic acid test
Data sourced from openFDA. This site is unofficial and independent of the FDA.