u s medical covid 19 direct fluorescence pcr test kit sale instructions

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  • COVID-19 Coronavirus Real Time PCR Kit - Instructions

    2021-5-12 · COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or r evoked sooner. Caution: Federal Law restricts this device to sale …

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  • Real-Time Fluorescent RT -PCR Kit for Detecting SARS

    2021-4-2 · The Real-Time Fluorescent RT -PCR Kit for Detecting SARS -CoV-2 is a molecular in vitro diagnostic test that aids in the detectionand diagnosis of SARS-CoV …

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  • Simplexa™ COVID -19 Direct - U.S. Food and Drug ...

    2021-7-23 · The Simplexa™ COVID-19 Direct assay is intended for use by qualified and trained clinical laboratory personnel specifically instructed and trained in the techniques of real -time PCR and in ...

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  • COVID-19 RT-PCR PNA KIT - U.S. Food and Drug

    2021-5-25 · The COVID-19 RT -PCR PNA Kit is intended for use by qualified clinical laboratory personnel specifically instructed and trained in the techniques of real -time PCR and in vitro diagnostic procedures.

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  • Instructions for LabGun™ COVID-19 RT-PCR Kit

    2020-9-23 · LabGunTM COVID-19 RT-PCR Kit is a real-time reverse transcription polymerase chain reaction (rRT-PCR) test intended for the qualitative detection of nucleic acid from the -CoV-2 in SARS ...

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  • Instruction for Use Fosun COVID-19 RT-PCR Detection Kit

    2020-12-28 · The Fosun COVID-19 RT-PCR Detection Kit is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in …

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  • U-TOP™ COVID-19 Detection Kit - U.S. Food and Drug ...

    2021-2-16 · The U-TOPTM COVID-19 Detection Kit is a one-step real-time RT-PCR test intended for the qualitative detection of nucleic acid from SARS-CoV-2 in oropharyngeal and …

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  • List of SARS-CoV-2 Diagnostic test kits and equipments ...

    2020-12-9 · FDA approves first COVID-19 direct-to-consumer test. Today, the U.S. Food and Drug Administration authorized LabCorp's Pixel COVID-19 Test Home Collection Kit …

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  • COVID-19 Coronavirus Real Time PCR Kit

    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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  • COVID-19 Coronavirus Real Time PCR Kit

    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.

    Get Price
  • Rapid Antigen Tests - WHO

    Covid-19 FDA Authorized PCR Saliva Test. If you feel like you are having a medical emergency, please call 9-1-1. If you are experiencing severe trouble breathing, continuous pain or pressure in your chest, feeling confused or having difficulty waking up, blue-colored lips or face, or any other emergency signs or symptoms, please seek immediate medical care.

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  • CCNC Point of Care COVID-19 Testing: Guidance for ...

    Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the first COVID-19 diagnostic test for self-testing at home and that provides rapid results. The Lucira COVID-19 All-In-One Test Kit is a molecular (real-time loop mediated amplification reaction) single use test that is intended to detect the novel coronavirus SARS-CoV-2 that causes COVID-19.

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