FDA 510(k)

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

Numéro K : K213822 · 2022-07-06

Date de décision2022-07-06

Code produitOCC

Comité consultatifMI

DécisionSubstantially Equivalent

Résumé du dispositif

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.

Questions fréquentes

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.

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Autres dossiers indiquant Roche Molecular Systems, Inc. en tant que demandeur

K260047cobas Strep A Nucleic acid test for use on the cobas Liat System (07341911190); cobas Strep A Quality Control Kit (07402678190)K260045cobas® Cdiff Nucleic acid test for use on the cobas® Liat® System (07454945190); cobas® Cdiff Positive and Negative Control Kit for use on the cobas® Liat® System (07454970190)K260021cobas® BV/CV K260917cobas CT/NG for use on the cobas 5800/6800/8800 systems; cobas TV/MG for use on the cobas 5800/6800/8800 systems K253759cobas liat CT/NG/MG nucleic acid test K253756cobas liat CT/NG nucleic acid test

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Dispositifs connexes (Code : OCC)

K262747ID NOW Influenza A & B 2; ID NOW RSV; ID NOW Strep A 2; ID NOW COVID-19 2.0Abbott Diagnostics Scarborough, Inc.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.

Source officielle

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