Milieu de prélèvement et de préservation moléculaire Copan eNAT®
Le NOUVEAU test Xpert Xpress CoV-2 plus fournit :
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, and not for any other viruses or pathogens. This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of 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.
*With early assay termination for positives, otherwise, the full test runtime is 30 minutes.
Nombre de tests : 10N° de réf. : XP3COV2/FLU/RSV-10