Diagnostic Collection Devices and Transfer Tubes

*The Aptima® and Panther Fusion® SARS-CoV-2 assays: These tests have not been FDA cleared or approved; These tests have been authorized by FDA under an EUA for use by authorized laboratories; These tests have been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens; and these tests are 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.

^†The Aptima Zika Virus assay: 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 RNA from Zika virus and diagnosis of Zika virus infection, 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 of Zika virus and/or diagnosis of Zika virus infection under section 564(b)(1) of the Act, 21 U.S.C.§ 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

^‡Refer to the appropriate product package insert for the indicated uses of the transfer tubes for each Hologic product.