Fetal RHD status
Detection of anti-HEV IgM
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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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Detection of anti-HEV IgM
Detection of anti-HEV IgM
Detection of anti-HEV IgM
Detection of anti-HEV IgM
Glycoprotein (GP) gene and/or nucleoprotein (NP) gene
Antibodies to Treponema pallidum
IgG antibodies to Epstein-Barr Virus (EBV) Viral Capsid Antigen (VCA)
Determination of IgG antibodies to SARS-CoV-2
Determination of IgM antibodies to SARS-CoV-2
Antibodies to Trypanosoma cruzi
SARS-CoV-2 RdRp | E and N genes
IgG and IgM antibodies to Treponema pallidum
SARS-CoV-2 ORF1 a/b non-structural region, nucleocapsid protein gene, Influenza A matrix gene, Influenza B non-structural protein gene
Antibodies (including IgG) to Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
Chikungunya virus (CHIKV) RNA | Dengue virus (DENV) RNA
Zika Virus RNA
Babesia (B. microti, B, duncani, B. divergens, and B. venatorum) DNA and RNA
West Nile Virus (WNV) RNA
Hepatitis E virus (HEV)
Parvovirus B19 genotypes 1, 2, and 3 DNA | Hepatitis A virus (HAV) genotypes I, II, and III RNA
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