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  • Logix Smart™ COVID-19 | Co-Diagnostics, Inc.

    The Logix Smart™ Coronavirus Disease 2019 (COVID-19) Test kit is an in vitro diagnostic test that uses our patented CoPrimer™ technology for the qualitative detection of the RNA from SARS-CoV-2 coronavirus (COVID-19).. The test operates using a single step real-time reverse transcriptase polymerase chain reaction (RT-PCR) process in lower respiratory tract fluids (e.g. bronchoalveolar ...

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  • Removal of COVID-19 Tests that Should No Longer Be

    2021-7-30 · abx294171 - COVID-19 IgG/IgM Rapid Test Kit: Removed - Should Not Be Distributed: H-Guard (China) Co., Ltd. Novel Coronavirus COVID-19 IgM/IgG Test Kit (colloidal gold) Removed - …

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  • LUCIRA™ CHECK IT COVID-19 Self-Test Now Available

    Warnings. This test has been authorized by FDA under an EUA for use by authorized laboratories. This test has not been FDA cleared or approved. This test 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 ...

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  • COVID-19 Antibody Rapid Test Kit | Coronavirus IgM

    2020-12-15 · The Ellume COVID-19 Home Test is the first of its kind to be granted an EUA and provides an essential new tool to help combat the COVID-19 pandemic. The Ellume self-test will help reduce the spread of COVID-19 through rapid self-detection, providing users with real-time results at home, enabling self-isolation and patient education on ...

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  • FDA authorizes Ellume COVID-19 Home Test as First

    2021-5-3 · Cue’s COVID-19 test is an OTC molecular test that provides results in 20 minutes. Cue has yet to announce a price or timeline for nationwide availability. Lastly, Lucira’s COVID-19 All-In-One Test Kit, similarly to Cue’s test, is a molecular test that takes 30 minutes to deliver results and is available over the counter directly through ...

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  • At-home COVID-19 rapid tests now commercially

    2020-1-26 · A ground-breaking test for the potentially fatal COVID-19 strain of coronavirus, is in the final stages of development at global health diagnostics company Randox Laboratories. The soon-to-be-launched test, developed on Randox’s patented Biochip Technology, will be available for immediate COVID-19 testing, but an additional enhanced multiplex ...

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  • Coronavirus test for 2019-nCoV strain available at

    *The Ellume COVID-19 Home Test has not been FDA cleared or approved; but has been authorized by the FDA under an emergency use authorization. This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens, and is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use ...

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  • CBP Officers Seize Fake COVID-19 Test Kits at LAX |

    2020-3-14 · Suspected Counterfeit Test Kits Mislabeled as “Purified Water Vials” LOS ANGELES - U.S. Customs and Border Protection (CBP) officers assigned to Los Angeles International Airport (LAX), International Mail Facility (IMF), intercepted a package containing suspected counterfeit COVID-19 test kits arriving from the United Kingdom. On March 12, 2020, CBP officers discovered six

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  • Apple grants $10 million to COVID-19 test collection

    2020-5-7 · Early Thursday morning, Apple announced it is awarding 10 million from its Advanced Manufacturing Fund plus manufacturing machinery design assistance to COVID-19 test kit …

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  • Covid-19 Diagnostics Market Size & Trends | Growth ...

    Covid-19 diagnosis is a contagious disease and is spreading across the globe with fast pace. Hence, there is an urgent requirement for the development of rapid diagnosis tests to prevent widespread of the disease. Moreover, significant ongoing researches are being conducted across the globe to develop rapid diagnosis test kits against Covid-19.

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  • COVID-19 tests: how they work and what's in

    2021-6-30 · Spartan’s test kit technology, known as the Cube, would have to be recalled and re-engineered. The lab-in-a-box — which sold for 8,000 each plus 70 plus for each test kit — had been ...

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  • Moonshot: Behind Spartan Bioscience’s troubled

    2020-10-7 · The 3 types of COVID-19 tests are a molecular (PCR) test, antigen ('rapid') test, and an antibody (blood) test. Find out how each test is performed and how accurate they are.

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  • 3 Types of COVID-19 Tests, and Which One Is the

    Lepu Medical Technology ( Beijing ) Co., Ltd was established in 1999. It is specialized in developing, manufacturing and marketing high-tech medical devices and equipment. Today, Lepu Medical has grown into a global leading group company in the fields of cardiovascular interventions, structural heart diseases, cardiac rhythm management ...

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  • Lepu Medical Technology Company - Medical Devices ...

    2020-4-15 · Abbott Laboratories has shipped 566,000 of its “rapid” molecular tests for the Coronavirus strain COVID-19 to all 50 U.S. states in less than a month.

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  • COVID-19 testing kits by CTK Biotech!

    Coronavirus Antigen Rapid Test Kit. In June 2020, JOYSBIO Biotechnology proudly released a new COVID-19 Antigen Rapid Test Kit (Colloidal Gold). The new coronavirus antigen test kit is a lateral flow immunoassay for the qualitative detection of SARS-COV-2 antigen (nucleocapsid protein) in upper respiratory samples with nasal swabs or saliva during the acute phase of infection.

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  • COVID-19 Antigen Rapid Test Kit - JOYSBIO Biotechnology

    Warnings. This test has been authorized by FDA under an EUA for use by authorized laboratories. This test has not been FDA cleared or approved. This test 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 ...

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  • COVID-19 Antibody Rapid Test Kit | Coronavirus IgM IgG ...

    This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests 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 …

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  • COVID-19 Home Saliva Test Kit: FDA EUA Authorized |

    The COVID-19 IgM/IgG Rapid Test by BioMedomics, Inc. demonstrates a combined sensitivity and specificity of 100% and ~99% respectively, making it one of the most accurate and reliable tests in the world. There is a critical, global need for serology assays that can complement nucleic acid (PCR) tests for diagnosing COVID-19 infection.

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  • COVID-19 IgM/IgG Rapid Test – BioMedomics Inc.

    2020-3-17 · A professor of the Vietnam Military Medical University holds a Covid-19 test kit it helped develop. Photo by VnExpress/Bich Ngoc. 20 countries and territories are looking to buy thousands of Vietnamese Covid-19 test kits, the director of a firm making them said Tuesday. The kits, which utilize molecular biology techniques, including reverse ...

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  • 20 countries, territories order Covid-19 test kits made in ...

    2020-9-17 · The test kit has also obtained a provisional authorisation from the Health Sciences Authority (HSA) for supply to hospitals and medical clinics for use on patients to diagnose Covid-19.

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  • Local company launches Covid-19 test kit that can speed

    2021-8-5 · Information. Download. 1. 02/07/2021. Performance evaluation of commercial kits for real time PCR for COVID-19 by ICMR identified validation centres. 2. 28/06/2021. List of Rapid Antigen Test Kits for COVID-19, validated by ICMR. 3.

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  • LabCorp’s at-home COVID-19 test kit is the first to be ...

    2020-3-27 · Feds seize 100 fraudulent COVID-19 test kits shipped from China, addressed to Portland man with prior ties to cannabis industry Updated Mar 27, 2020; Posted Mar 27, 2020 4

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