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FDA 510(k)

cobas Influenza A/B & RSV nucleic acid test for use on the cobas Liat System

K-Number: K213822 · 2022-07-06

ApplicantRoche Molecular Systems, Inc.
Decision Date2022-07-06
Product CodeOCC
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

cobas Influenza A/B & RSV nucleic acid test for use on the cobas Liat System 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 2022-07-06 under 510(k) number K213822. The device is classified under product code OCC. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the cobas Influenza A/B & RSV nucleic acid test for use on the cobas Liat System?

cobas Influenza A/B & RSV nucleic acid test for use on the cobas Liat System is a medical device that received FDA 510(k) clearance on 2022-07-06. The listed applicant is Roche Molecular Systems, Inc.. The 510(k) number is K213822.

When did cobas Influenza A/B & RSV nucleic acid test for use on the cobas Liat System receive FDA 510(k) clearance?

cobas Influenza A/B & RSV nucleic acid test for use on the cobas Liat System received FDA 510(k) clearance on 2022-07-06, under 510(k) number K213822.

Who is the listed applicant for cobas Influenza A/B & RSV nucleic acid test for use on the cobas Liat System?

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 Influenza A/B & RSV nucleic acid test for use on the cobas Liat System?

The FDA product code for cobas Influenza A/B & RSV nucleic acid test for use on the cobas Liat System is OCC.

Other records listing Roche Molecular Systems, Inc. as applicant

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Related Devices (Code: OCC)

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.

K254139BioCode® Respiratory Pathogen Panel (RPP)Applied BioCode, Inc.K242613NxTAG® Respiratory Pathogen PanelLuminex Molecular Diagnostics, Inc.K232775ID NOW Influenza A & B 2Abbott Diagnostics Scarborough, Inc.K231017Panther Fusion AdV/hMPV/RV AssayHologic, Inc.K210234cobas Influenza A/B & RSV Nucleic acid test for use on the cobas Liat SystemRoche Molecular Systems, Inc.K201505Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control PackDiasorin Molecular, LLC

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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