Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

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

K-Number: K231306 · 2023-06-01

ApplicantRoche Molecular Systems, Inc.
Decision Date2023-06-01
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 2023-06-01 under approval number K231306. 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 2023-06-01. It is manufactured by Roche Molecular Systems, Inc.. The 510(k) number is K231306.

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 2023-06-01, under approval number K231306.

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

NCT06840938 Physiological Manipulation and Surface Electrical Stimulation in Post Stroke Dysphagia Patients COMPLETED

Other Devices by Roche Molecular Systems, Inc.

K171770cobas Cdiff Nucleic acid test for use on the cobas Liat System K163184cobas® CT/NG v2.0 Test K173887cobas CT/NG for use on cobas 6800/8800 systems K172913cobas Factor II and Factor V Test DEN190016cobas vivoDx MRSA K191729Cobas Influenza A/B Nucleic Acid Test for Use on the Cobas Liat System

View all 47 devices →

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® K241580Alinity m SARS-CoV-2 AMP Kit (09N78-096); Alinity m SARS-CoV-2 CTRL Kit (09N78-086)Abbott Molecular

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.

↑