DeviceClearance

K200065

Substantially Equivalent

cobas Influenza A/B 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, cobas Strep A Nucleic acid test for use on the cobas Liat System

Applicant
Roche Molecular Systems, Inc.
Product code
OCC
Advisory panel
Microbiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Pleasanton, CA, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code OCC

product code OCC
Death
3
Malfunction
706
Total
709

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.