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EUA for the cobas SARS-CoV-2 test

FDA

On March 12, 2020, the FDA issued an Emergency Use Authorization (EUA) to authorize the emergency use the Roche Molecular Systems, Inc.(RMS) cobas SARS-CoV-2 test for use on the cobas 6800/8800 Systems for the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal and oropharyngeal swab samples from patients who meet COVID-19 clinical and/or epidemiological criteria, pursuant to Section 564 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. §360bbb-3).

The cobas SARS-CoV-2 test is for use only under EUA in United States (U. S.) in laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform moderate complexity tests and in U.S. laboratories certified under CLIA to perform high complexity tests, by clinical laboratory personnel who have received specific training on the use of the cobas 6800/8800 Systems.

SOURCE: FDA

[pdf_attachment file=”1″ name=”FDA letter of authorization”]
[pdf_attachment file=”3″ name=”factsheet for health care providers”]
[pdf_attachment file=”4″ name=”factsheet for patients”]
[pdf_attachment file=”2″ name=”qualitative assay for cobas system”]