Empirical EUA Statement
The QuantiTASE Plus One Step RT-qPCR SARs-CoV-2 assay kit is available for In Vitro Diagnostic (IVD) use in accordance with the May 11 2020 FDA guidance document titled: Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised)
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QuantiTASE Universal RT-qPCR Kit | QuantiTASE PLUS Universal RT-qPCR Kit | QuantiTASE Two-Step RT-qPCR Reagent Kit | 4X InhibiTAQ HotStart qPCR MasterMix | 4X InhibiTAQ PLUS HotStart qPCR MasterMix | 2X qPCR Probe MasterMix | FlashTaq 2X MasterMix | rEVAlution2x qPCR MasterMix | RTScript™ cDNA Synthesis Kit | RTScript™ cDNA Transcriptase Enzyme | WarmStart RTScript™ Reverse Transcriptase
Empirical Bioscience’s QuantiScript RT-qPCR, RTScript™ Transcriptase, and InhibiTaq qPCR product lines have been tested and meet the performance requirements for 2019-nCoV detection as outlined by the CDC when used in conjunction with a EUA approved Primer & Probe Kit. Empirical Bioscience is an FDA registered and ISO13485:2016 certified manufacturer of Molecular Biology Reagents.
For Research Use Only.
Those using Empirical Bioscience products are responsible for ensuring they are used in compliance with the appropriate regulatory requirements.
Empirical Bioscience recommends that users within the USA jurisdiction follow the nCoV2/COVID testing guidelines established by the FDA and CDC. Links for current versions of these FDA and CDC documents are listed below.
Please note, these links are for informational purposes only. While we will do our best to make sure that links to these documents are up-to-date, we cannot guarantee they are the most recent versions. Users are responsible for verifying they are using the latest relevant information.