medical covid 19 test diagnostic kit on sale use to spain

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  • Rapid COVID-19 IgM/IgG Combo Test Kit - Instructions

    COVID-19 IgM/IgG Rapid Test. Medakit has developed and launched one of the world’s first rapid point-of-care lateral flow immunoassays for the diagnosis of coronavirus infection. The test has been used widely by the Chinese CDC to combat infections and is now available globally. This test detects both early marker and late marker, IgM/IgG ...

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  • Q&A on in vitro diagnostic medical device conformity ...

    2021-7-16 · There’s also the fact that a self-diagnosis test performed at home doesn’t get you an official document confirming you tested negative for Covid-19 as antigen tests performed by clinics and labs do. Spain’s Health Ministry is currently deciding on its MO for incorporating the results of self-test kits into its health database.

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  • HS classification reference for Covid-19 medical supplies

    Medical Diagnostic Test instruments and apparatus (902780) exports by country in 2018 Additional Product information: Instruments used in clinical laboratories for In Vitro Diagnosis.Colorimetric end tidal CO2 detector, sizes compatible with child and adult endotracheal tube.

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  • Q&A on in vitro diagnostic medical device conformity ...

    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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  • REGULATORY REQUIREMENTS FOR COVID-19 RAPID

    2021-7-2 · 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 authorization is terminated or revoked sooner.

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  • HS classification reference for Covid-19 medical supplies

    2021-6-28 · COVID-19 tests - Q&A on in vitro diagnostic medical device conformity assessment and performance in the context of COVID-19 5 The manufacturer’s information accompanying RUO products must explicitly state that they are for research use only, and they must not have instructions regarding diagnosis or other medical use, which

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  • Diagnostic Testing for COVID-19

    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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  • HS classification reference for Covid-19 medical supplies

    COVID-19 diagnostic test is real-time reverse-transcriptase polymerase chain reaction (rRT-PCR). These tests were created to be highly specific to the SARS-CoV-2 virus, thereby minimizing false positive results, and to detect low viral loads in respiratory samples. 5 These types of tests require

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  • HS classification reference for Covid-19 medical supplies

    1. COVID-19 Rapid Test is for in vitro diagnostic use only. The test should be performed using serum, plasma or whole blood samples only. Neither the quantitative value nor the rate of increase in COVID-19 antibody concentration can be determined by this qualitative test. 2. In the early onset of fever, anti-COVID-19 IgM concentrations may be ...

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  • List of SFDA Emergency Use Authorization (EUA) and

    2020-3-3 · The SARS-CoV-2 test was developed by OSANGHealthcare of Korea to provide a fast and easy-to-use diagnostic solution to contain the expansion of the virus and to rapidly identify clusters of infection. The kit detects the RdRP gene, E gene and N gene …

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