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
Anti-SARS-CoV-2 Antibody Detection
Antibodies (including IgG) to Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
Chikungunya virus (CHIKV) RNA and dengue virus (DENV) RNA Detection
Chikungunya virus (CHIKV) RNA | Dengue virus (DENV) RNA
Zika Virus RNA
Babesia DNA and RNA Detection Test
Babesia (B. microti, B, duncani, B. divergens, and B. venatorum) DNA and RNA
West Nile Virus (WNV) RNA
Hepatitis E Virus RNA Screening
Hepatitis E virus (HEV)
Parvovirus B19 DNA Quantification, Hepatitis A Virus RNA Detection
Parvovirus B19 genotypes 1, 2, and 3 DNA | Hepatitis A virus (HAV) genotypes I, II, and III RNA
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