SARS-CoV-2, Influenza A, Influenza B Detection and Differentiation
SARS-CoV-2 ORF1 a/b non-structural region, nucleocapsid protein gene, Influenza A matrix gene, Influenza B non-structural protein gene
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The consultation procedure is relevant to you, if you are a manufacturer of a class D device that falls under the following conditions:
(1) the absence of common specifications for the class D device in question, AND
(2) where it is also the first certification for that type of device.
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SARS-CoV-2, Influenza A, Influenza B Detection and Differentiation
SARS-CoV-2 ORF1 a/b non-structural region, nucleocapsid protein gene, Influenza A matrix gene, Influenza B non-structural protein gene
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