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Detectr Boost - Model SARS-CoV-2 - Reagent Kit
A CRISPR-based detection solution for SARS-CoV-2. Mammoth Biosciences has developed a turnkey workstation to run a CRISPR-based SARS-CoV-2 molecular assay based on automated liquid handling equipment. This high throughput system can perform thousands of tests per day with minimal user interaction. CLIA high complexity laboratories will be able to significantly increase capacity with minimal FTE support to meet increasing demand. Learn more from our recent press release.
*DETECTR BOOST is a qualitative test for the detection of nucleic acid from SARS-CoV-2 in nasopharyngeal, anterior nasal, mid-turbinate nasal or oropharyngeal swab specimens from individuals suspected of COVID-19 by their healthcare provider. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform high complexity tests.
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. § 360bbb- 3(b)(1), unless the declaration is terminated or authorization is revoked sooner.