medical covid 19 direct fluorescence pcr test diagnostic kit on sale use to indonesia

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  • COVID-19 Coronavirus Real Time PCR Kit - Instructions

    2021-5-12 · The COVID-19 Coronavirus Real Time PCR Kit is a real-time fluorescent RT-PCR based assay intended for the qualitative detection of SARS-2 nucleic acid …

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  • Simplexa™ COVID -19 Direct - FDA

    BGI’s Real-Time Fluorescent RT-PCR kit for detecting 2019-nCoV (SARS-CoV-2) is a qualitative in vitro nucleic acid amplification assay used to detect SARS-CoV-2 using reverse transcription PCR from throat swab and Bronchoalveolar Lavage Fluid(BALF) samples. The kit is widely used for rapid detection and outbreak control of COVID-19 in China.

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  • Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic

    2021-8-15 · CareStart COVID-19 Antigen Rapid Test Kit Packed 5 Tests Everything Included SALE 10/Test. 95.00 50.00. - (21-22)% New. Quick View. Select options. The CareStart COVID-19 Antigen Rapid Test. FDA Emergency Use Authorized. Made in USA. 288.00 – 1,375.00.

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  • Rapid Antigen Tests - WHO

    BGI’s Real-Time Fluorescent RT-PCR kit for detecting 2019-nCoV (SARS-CoV-2) is a qualitative in vitro nucleic acid amplification assay used to detect SARS-CoV-2 using reverse transcription PCR from throat swab and Bronchoalveolar Lavage Fluid(BALF) samples. The kit is widely used for rapid detection and outbreak control of COVID-19 in China.

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  • HS classification reference for Covid-19 medical supplies

    Due to the Coronavirus Public Health Emergency, the FDA updated its Policy for Diagnostic Tests for COVID-19 on March 16, 2020. Included in this update is guidance for commercial manufacturers, such as our test, for screening tests that identify antibodies (e.g., IgM, IgG) to SARS-CoV-2 …

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  • COVID-19 Diagnostics In Context For updated version see ...

    2020-4-2 · CerTest Biotec launches CE Marked COVID-19 diagnostic test for the BD MAX™ System. CerTest Biotec, along with BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced that the VIASURE SARS-CoV-2 Real Time PCR Detection Kit adapted for the BD MAX™ System has been CE marked to the IVD Directive (98/79/CE).

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  • Diagnostic detection of 2019-nCoV by real-time RT-PCR

    Our Coronavirus Test (COVID-19) requires a gentle lower nasal swab to be collected by you in the home. The test-kit comes with a UPS next day air return shipping label to send your sample back to our lab. Your sample is analysed in our lab using gold standard RT-PCR/TMA to confirm the presence of SARS-CoV-2, the virus that causes COVID-19.

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  • Considerations on the use of self-tests for COVID-19 in ...

    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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  • COVID-19: POINT OF CARE (POC) TESTING

    2020-3-19 · March 19, 2020. The Food and Drug Administration (FDA) has released today a list of approved COVID-19 test kits for commercial use. These are PCR based reagent kits used in laboratories and not point-of-care or do-it-yourself kits. The companies have complied with the requirements as stated in the FDA Memorandum No. 2020-006 entitled ...

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  • STANDARD Q COVID-19 Ag Test - World Health

    Meridian Curian HpSA Meridian Curian Fluorescent Immunoassay Analyser Anatolia Geneworks SARS-CoV-2 PCR solution Dynamiker SARS-CoV-2 Ag COVID-19 Rapid Test ANATOLIA GENEWORKS BOSPHORE SARS-CoV-2/Flu RSV PCR Panel Kit Anatolia Geneworks Bosphore Novel Coronavirus (2019-nCoV) Detection Kit v4 DiaPro COVID-19 IgG, IgM and IgG Confirmation ...

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