BioGX Xfree - COVID-19 Direct RT-PCR Test Kit
The Xfree™ COVID-19 Direct RT-PCR test is offered lyophilized in a single vial, in the trusted BioGX Sample-Ready™ “Just Add Water” format where no other reagent is required. The test is available for the most ubiquitous real-time PCR platforms already available in thousands of laboratories. The fast and simple workflow is designed to help laboratories to increase their testing capacity without adding expert molecular staff or new automation.
This product has not been FDA cleared or approved but has been authorized for emergency use by FDA under an EUA for use by authorized laboratories. This product has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. 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 COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
COVERAGE
- Covers new SARS-CoV-2 strains
SIMPLE WORKFLOW
- Easy-to-Use, Sample-to-Result application
COST EFFECTIVE AND ACCURATE
- Competitive promotional pricing with volume discounts and highly accurate results
HIGH-THROUGHPUT WORKFLOW
- 96 to 384 test results in 80 minutes
HEAT INACTIVATION
- Achieved during RT-PCR
MULTI-PLATFORM COMPATIBILITY
- Compatible with Bio-Rad CFX Touch™, QuantStudio™ & BD MAX™