At Fluidigm, we empower our customers to reveal meaningful insights in health and disease, identify actionable markers to inform life decisions and accelerate the development of more effective therapies.
Fluidigm develops, manufactures, and markets research products for life science analytical and preparatory systems for use in mass cytometry, high-throughput genomics, and single cell genomics applications. Our research tools provide automated cost-effective solutions for PCR-based analysis and NGS library preparation including RNA-Seq and Targeted DNA sequencing.
The Advanta Dx SARS-CoV-2 RT-PCR Assay is for In Vitro Diagnostic Use. It is for Use Under Emergency Use Authorization Only. Rx Only.
It has not been FDA cleared or approved. It has been authorized by FDA under an EUA for use by authorized laboratories. It has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. It 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.
Other Fluidigm products are For Research Use Only. Not for use in diagnostic procedures.
