Cobas Influenza A/B & RSV Nucleic Acid Test For Use On The Cobas Liat System

Respiratory Virus Panel Nucleic Acid Assay System

Roche Molecular Systems, Inc.

The following data is part of a premarket notification filed by Roche Molecular Systems, Inc. with the FDA for Cobas Influenza A/b & Rsv Nucleic Acid Test For Use On The Cobas Liat System.

Pre-market Notification Details

Device IDK213822
510k NumberK213822
Device Name:Cobas Influenza A/B & RSV Nucleic Acid Test For Use On The Cobas Liat System
ClassificationRespiratory Virus Panel Nucleic Acid Assay System
Applicant Roche Molecular Systems, Inc. 4300 Hacienda Drive Pleasanton,  CA  94588 -2722
ContactKaitlyn Hameister
CorrespondentKhushvanreep Singh
Roche Molecular Systems, Inc. 4300 Hacienda Drive Pleasanton,  CA  94588 -2722
Product CodeOCC  
CFR Regulation Number866.3980 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-12-08
Decision Date2022-07-06

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