Innovative qSTAR technology transforms molecular diagnostics and lab efficiency with fast direct amplification within 20 minutes on open RT-PCR systems.
HIGH THROUGHPUT / RAPID / ACCURA TE
This test has not been FDA cleared or approved but has been authorized by FDA for emergency use 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 the emergency use of 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 Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
