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    2021-6-2 · Antigen Rapid test or RT-qPCR test is recommended to identify acute COVID-19. The COVID-19 Viral Antigen Detection kit detects the Nucleocapsid (N) protein of the SARS-CoV-2 virus from naso- or oropharyngeal swabs, while the ProTect™ COVID-19 RT-qPCR kit is based on the direct molecular diagnostics of the virus RNA.

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    2021-4-30 · The CareStart™ COVID-19 Antigen test is a lateral flow immunochro- matographic assay intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal or

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    South Korean IVD Company, SUGENTECH’s, COVID-19 IgM-IgG Rapid Test Listed on FDA. SEOUL, South Korea - April 8, 2020 - ( Newswire.com ) ‘SGTi-flex COVID-19 IgM&IgG’ is an immunochromatographic test kit for the qualitative determination of COVID-19’s IgM and IgG antibodies in whole blood (finger prick or venous), serum or plasma.

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    SGTi-flex COVID-19 IgM&IgG is a gold nanoparticle-based immunochromatographic test kit for qualitative determination of COVID-19’s IgM and IgG antibodies in human whole blood (finger prick or venous), serum or plasma. The kits are accurate and easy to use and results can be observed with the naked eye within 10 minutes.

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    2021-7-28 · The table below, based on the FDA’s website, lists all companies with U.S. locations offering COVID-19 immunity tests with an FDA EUA. The FDA's website was last updated on August 17th. Information in the table includes the tests each company offers, the type of technology each test depends on, and each test’s PPV (Positive Predictive Value ...

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    2021-7-13 · EUAs for Coronavirus Disease 2019 (COVID-19) Learn more about medical device Emergency Use Authorizations related to Coronavirus Disease 2019 (COVID-19).

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  • Emergency Use Authorizations for Medical Devices | FDA

    Access Bio’s mission is to improve the lives and well-being of people around the world. Through the development of in vitro diagnostics technology, Access Bio has successfully commercialized the highest quality products to battle malaria and other serious diseases.. We are a trusted partner to international public health agencies and organizations, including the World Health Organization ...

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    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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    2021-7-28 · Home Health UK is committed to providing the highest quality of simple, reliable diagnostic test kits for drug testing kits, pregnancy tests and general health tests, which can be easily carried out in the home.Our test kits range from allergy tests, blood glucose meter, digital ovulation tests, clearblue pregnancy tests as well as male and female fertility test kits to, urine infection ...

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    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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    The Antigen Rapid Test Kit for COVID-19 is based on a specific antibody-antigen reaction and on the immunoassay technology on a nasal swab sample. The test is to be used as an aid in the diagnosis of coronavirus infection (COVID-19), which is caused by 2019-nCoV. The test …

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  • COVID-19 Lateral Flow Tests - The UK's Leading

    Diagnostic Testing Strips & Kits. COVID-19 Lateral Flow Tests. Rapid lateral flow tests help to find cases in people who may have no symptoms but are still infectious and can give the virus to others. The test usually involves taking a sample (nasopharyngeal, nasal only and/or throat) using a swab. You can get a result in as little as 15 minutes.

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  • HSA Expedites Approval of COVID-19 Diagnostic Tests

    Update: From 1 June 2021, HSA will stop accepting new provisional authorisation applications for COVID-19 test. For tests that have been granted provisional authorisation, the authorisation will remain valid till 31 December 2021. From 1 January 2022, all COVID-19 tests supplied in Singapore should be registered with HSA or received ...

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    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. § 360bbb-3(b)(1), unless the authorization is …

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