Detection of anti-HEV IgM
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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Detection of anti-HEV IgM
Plasmodium DNA and RNA Detection
Detection of anti-HEV IgM
SARS-CoV-2 genomic RNA Detection
SARS-CoV-2 RdRp | E and N genes
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
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
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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