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    2017-5-5 · 'in vitro diagnostic medical device' means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue ...

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    2017-5-5 · 'in vitro diagnostic medical device' means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue ...

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    2021-2-23 · The COVID-19 Antigen Rapid Test is a rapid membrane-based lateral flow immunoassay for the qualitative detection of SARS-CoV-2 antigens in human nasopharyngeal swab specimens. The use of a COVID-19 Antigen Rapid Test allows you to detect the presence of SARS-CoV-2 virus antigens in our body and to take initial precautionary isolation measures in order to reduce further spread of the virus.

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    2021-9-4 · 1. INTRODUCTION. Coronavirus disease 2019 (COVID-19), a respiratory disease that first appeared in China, has spread globally to >200 countries, resulting in over 2.97 million confirmed patients and 206 000 deaths as of April 27, 2020. 1 Since its outbreak last year, research groups used whole genome/RNA sequencing and identified viral cause of COVID-19, which possesses genetic sequence …

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  • Different types of COVID-19 tests explained

    2020-11-12 · However, not all molecular tests, including PCR methods, are perfect. Some lesser testing platforms have reported false negative rates as high as 15% to 20%. Both of UC Davis Health's tests, the rapid COVID-19/flu test and the lab test for COVID-19, are highly sensitive, highly specific PCR tests.

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