Hepatitis E virus IgM Detection

Date of reception of the dossier


Notified Body number


Internal PECP dossier #

In vitro diagnostic medical device

Assay using chemiluminescent immunoassay (CLIA) technology for the qualitative determination of IgM antibodies to hepatitis E virus (Anti-HEV IgM) in human serum and plasma samples included specimens collected post- mortem (non-heart beating).

It is intended as an aid in the diagnosis of HEV infection in individuals with or without symptoms of hepatitis. It is also intended as a screening test for organ, tissue and cells post- mortem donors.

Intended purpose


what is detected and/or measured
please specify the analyte(s) or marker(s), e.g. SARS-CoV-2 spike protein, Kel1 (K)


function of the device
e.g. diagnosis, aid to diagnosis, monitoring, determining the infectious load, tissue typing etc


the specific disorder, condition or risk factor of
interest that it is intended to detect, define or
differentiate e.g. hepatitis C infection, exposure to SARS-CoV-2, risk of HIV transmission in blood transfusion etc.

HEV infection


whether it is automated or not

Automated assay


whether it is qualitative, semi-quantitative or

Qualitative assay


type of specimen(s)
e.g. whole blood, serum, saliva etc

Serum and plasma samples, including specimens collected post-mortem (non-heart beating).


where applicable, the testing population
e.g. persons with specific health conditions,
persons with specific symptoms, children in a
certain age range

Individuals with or without symptoms of hepatitis.


intended user

For Laboratory Professional Use Only



principle of the assay method or principles of operation of the instrument e.g. real-time PCR, qualitative PCR, digital PCR, sandwich immunoassay, competitive immunoassay, immunoturbidimetric assay etc.

Chemiluminescence immunoassay (CLIA).

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