+ In development for use with cobas 5800
** HIV-1, HBV and HIV-1/2 Qual are pending PMA. HCV is pending 510(k) for use with cobas 5800.
‡ For Life Science Research Use Only. Not for use in diagnostic procedures.
† This product is in development. This product is not available for use in the U.S.
* This test will be submitted to the FDA as a Master File and will not have a regulatory classification, and will not be cleared, licensed or approved by the FDA.
§ This test has not been FDA cleared or approved;
This test has been authorized by FDA under an EUA for use by authorized laboratories;
This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens; and
This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb- 3(b)(1), unless the authorization is terminated or revoked sooner
|| This workflow for the test has not been reviewed by the FDA. The test has been validated but FDA’s independent review of this validation is pending. This pooling workflow is distributed in accordance with Section IV.C of the FDA policy for Coronavirus Disease-2019 Tests during the Public Health Emergency (Revised) at https://www.fda.gov/media/135659.