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Mar 18, 2020 · The test kits are rapid chromatographic immunoassays (configured like a home pregnancy test) to detect IgM and IgG antibodies to COVID-19 SARS-CoV-2 About Us Epitope Diagnostics, Inc.This innovative device has been patented (US 7,780,915), FDA 510(k) cleared, and CLIA-waived since 2005. This platform has gone on to be the basis of all our rapid test kit, including the European CE certified OTC kit, EpiTuub iFOB test. ISO Certification. EDI is an ISO 13485:2016 certified company. Our certificate can be found here.
Apr 09, 2020 · The following day, the Department of Health in the Philippines authorized the use of the companys rapid test kit for the detection of COVID-19. The EU gave its At-Home Coronavirus (COVID-19) Test Kit EverlywellTest for the coronavirus that causes COVID-19 from the convenience and safety of your own home. Learn more about our at-home coronavirus test kit today. The partner labs processing the COVID-19 Test are complying with the FDAs Emergency Use Authorization guidance for COVID-19 testing. COVID-19 Home Saliva Test Kit:FDA EUA Authorized Weve partnered with labs operating under the Emergency Use Authorization guidelines issued by the FDA. Our COVID-19 home saliva test kits ship with the highest priority postage for the fast delivery to your home and back to the lab. Within 72 hours of the lab receiving your sample, you will
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Feb 06, 2020 · Each test kit can test approximately 700 to 800 patient specimens. Additional test kits will be produced and made available for ordering in the future from the IRR. At this time, each laboratory that places an order will receive one 2019-nCoV test kit. The IRR is accepting orders for 2019-nCoV tests from qualified laboratories. Trxade Group, Inc. Files FDA Emergency Use Authorization The rapid test is intended to be administered at the point of care with no additional instrumentation needed. Trxade has announced 20,000 units available for purchase as pre-orders as soon as Coronavirus Test Kit Demand to Drive These 3 Stocks NasdaqMar 23, 2020 · A few companies have come to limelight with their rapid diagnostic test kit in the last few days. On Mar 20, the FDA approved the first coronavirus test kit that can be conducted entirely at the