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 liat SARS-CoV-2 & Influenza A/B v2 nucleic acid test

K-Number: K243400 · 2025-04-25

ApplicantRoche Molecular Systems, Inc.
Decision Date2025-04-25
Product CodeQOF
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

cobas liat SARS-CoV-2 & Influenza A/B v2 nucleic acid test is the device name listed in this FDA 510(k) record. The listed applicant is Roche Molecular Systems, Inc.. It received FDA 510(k) clearance on 2025-04-25 under 510(k) number K243400. 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 liat SARS-CoV-2 & Influenza A/B v2 nucleic acid test?

cobas liat SARS-CoV-2 & Influenza A/B v2 nucleic acid test is a medical device that received FDA 510(k) clearance on 2025-04-25. The listed applicant is Roche Molecular Systems, Inc.. The 510(k) number is K243400.

When did cobas liat SARS-CoV-2 & Influenza A/B v2 nucleic acid test receive FDA 510(k) clearance?

cobas liat SARS-CoV-2 & Influenza A/B v2 nucleic acid test received FDA 510(k) clearance on 2025-04-25, under 510(k) number K243400.

Who is the listed applicant for cobas liat SARS-CoV-2 & Influenza A/B v2 nucleic acid test?

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

What is the FDA product code for cobas liat SARS-CoV-2 & Influenza A/B v2 nucleic acid test?

The FDA product code for cobas liat SARS-CoV-2 & Influenza A/B v2 nucleic acid test 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.

NCT05765396SARS-CoV-2/COVID-19 Study of Next Generation Non-Invasive Passive Detection Technologies (Level42)COMPLETED

Other records listing Roche Molecular Systems, 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.

K260021cobas® BV/CVK260917cobas CT/NG for use on the cobas 5800/6800/8800 systems; cobas TV/MG for use on the cobas 5800/6800/8800 systemsPMA P190028KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUSK253759cobas liat CT/NG/MG nucleic acid testK253756cobas liat CT/NG nucleic acid testPMA P140023Somatic gene mutation detection system

View all 47 devices →

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.

K252932Fast PCR Mini Respiratory PanelAutonomous Medical Devices IncorporatedK252269FINDER Flu A&B/SARS-CoV-2 TestBaebies, Inc.K251742VELO Respiratory TestLex Diagnostics LimitedK251978LIAISON NES FLU A/B, RSV & COVID-19Diasorin Molecular, LLCK252387Simplexa™ COVID-19/ Flu A/B & RSV Direct (MOL4450); Simplexa™ COVID-19/ Flu A/B & RSV Positive Control Pack (MOL4460)Diasorin Molecular, LLCK250080QIAstat-Dx Respiratory Panel Plus; QIAstat-Dx Respiratory Panel MiniQIAGEN GmbH

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.

↑