Cobas Cdiff Nucleic Acid Test For Use On The Cobas Liat System

C. Difficile Toxin Gene Amplification Assay

Roche Molecular Systems, Inc.

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

Pre-market Notification Details

Device IDK210385
510k NumberK210385
Device Name:Cobas Cdiff Nucleic Acid Test For Use On The Cobas Liat System
ClassificationC. Difficile Toxin Gene Amplification Assay
Applicant Roche Molecular Systems, Inc. 4300 Hacienda Drive Pleasanton,  CA  94588 -2722
ContactGaila Balniene
CorrespondentGaila Balniene
Roche Molecular Systems, Inc. 4300 Hacienda Drive Pleasanton,  CA  94588 -2722
Product CodeOZN  
CFR Regulation Number866.3130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-02-09
Decision Date2021-09-09

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