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

FDA 510(k)

cobas eplex respiratory pathogen panel 3

K-Number: K262938 · 2026-10-30

ApplicantGenMark Diagnostics, Inc.
Decision Date2026-10-30
Product CodeQOF
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

cobas eplex respiratory pathogen panel 3 is the device name listed in this FDA 510(k) record. The listed applicant is GenMark Diagnostics, Inc.. It received FDA 510(k) clearance on 2026-10-30 under 510(k) number K262938. The device is classified under product code QOF. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the cobas eplex respiratory pathogen panel 3?

cobas eplex respiratory pathogen panel 3 is a medical device that received FDA 510(k) clearance on 2026-10-30. The listed applicant is GenMark Diagnostics, Inc.. The 510(k) number is K262938.

When did cobas eplex respiratory pathogen panel 3 receive FDA 510(k) clearance?

cobas eplex respiratory pathogen panel 3 received FDA 510(k) clearance on 2026-10-30, under 510(k) number K262938.

Who is the listed applicant for cobas eplex respiratory pathogen panel 3?

The FDA 510(k) record lists GenMark Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for cobas eplex respiratory pathogen panel 3?

The FDA product code for cobas eplex respiratory pathogen panel 3 is QOF.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT04745156A Study Using Brain Stimulation and Behavioral Therapy to Increase Extent of Resection in Low-Grade GliomasNOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED

Other records listing GenMark Diagnostics, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K110786ESENSOR WARFARIN SENSITIVITY SALIVA TEST

Related Devices (Code: QOF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K263333Xpert Xpress CoV-2/Flu plusCepheid®K263120Xpert Xpress CoV-2/Flu plusCepheid®K261336Xpert Respiratory PanelCepheidK263054BIOFIRE Respiratory Panel 2.1 (RP2.1)Biofire DiagnosticsK261837FINDER Flu A&B/SARS-CoV-2 TestBaebies, Inc.K252932Fast PCR Mini Respiratory PanelAutonomous Medical Devices Incorporated

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.

↑