* Not available for sale on the cobas 5800 in the U.S.
** Pending PMA approval for use with the cobas 5800 in the U.S.
# Pending 510(k) clearance for use with the cobas 5800 in the U.S.
‡ For 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 product has not been FDA cleared or approved, but has been authorized by FDA under an EUA for use by authorized laboratories;
SARS-CoV-2 & SARS-CoV-2 Duo
This product has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens;and
SARS-CoV-2 & Flu A/B
This test has been authorized only for the simultaneous qualitative detection and differentiation of nucleic acids from SARS-CoV-2, influenza A virus, and influenza B virus, and not for any other viruses or pathogens; and
SARS-CoV-2, SARS-CoV-2 Duo, & SARS-CoV-2 & Flu A/B
This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics 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.
MPXV
This product has been authorized only for the detection of nucleic acid from monkeypox virus, not for any other viruses or pathogens; and
The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of infection with the monkeypox virus, including in vitro diagnostics that detect and/or diagnose infection with non-variola Orthopoxvirus, under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
¶ This product has been approved by FDA for use by authorized laboratories certified under CLIA to perform moderate complexity testing.
