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FDA 510(k)

cobas® SARS-CoV-2 Qualitative for use on the cobas® 5800/6800/8800 Systems

K-Number: K240867 · 2025-02-11

ApplicantRoche Molecular Systems, Inc.
Decision Date2025-02-11
Product CodeQQX
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

cobas® SARS-CoV-2 Qualitative for use on the cobas® 5800/6800/8800 Systems is a medical device manufactured by Roche Molecular Systems, Inc.. It received FDA 510(k) clearance on 2025-02-11 under approval number K240867. The device is classified under product code QQX. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the cobas® SARS-CoV-2 Qualitative for use on the cobas® 5800/6800/8800 Systems?

cobas® SARS-CoV-2 Qualitative for use on the cobas® 5800/6800/8800 Systems is a medical device that received FDA 510(k) clearance on 2025-02-11. It is manufactured by Roche Molecular Systems, Inc.. The 510(k) number is K240867.

When was cobas® SARS-CoV-2 Qualitative for use on the cobas® 5800/6800/8800 Systems approved by the FDA?

cobas® SARS-CoV-2 Qualitative for use on the cobas® 5800/6800/8800 Systems received FDA 510(k) clearance on 2025-02-11, under approval number K240867.

What company makes cobas® SARS-CoV-2 Qualitative for use on the cobas® 5800/6800/8800 Systems?

cobas® SARS-CoV-2 Qualitative for use on the cobas® 5800/6800/8800 Systems is manufactured by Roche Molecular Systems, Inc..

What is the FDA product code for cobas® SARS-CoV-2 Qualitative for use on the cobas® 5800/6800/8800 Systems?

The FDA product code for cobas® SARS-CoV-2 Qualitative for use on the cobas® 5800/6800/8800 Systems is QQX.

Related Clinical Trials

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Related Devices (Code: QQX)

K211079BioFire COVID-19 Test 2Biofire Defense, LLC K213804cobas SARS-CoV-2 Qualitative for use on the cobas 6800/8800 SystemsRoche Molecular Systems, Inc. K212147Simplexa COVID-19 DirectDiasorin Molecular, LLC K221460BioFire COVID-19 Test 2Biofire Defense, LLC K230440Xpert® Xpress CoV-2 plusCepheid® K231306cobas SARS-CoV-2 Qualitative for use on the cobas 5800/6800/8800 SystemsRoche Molecular Systems, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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