Anti-SARS-CoV-2 IgM Antibody Detection
Date of reception of the dossier
24.11.2021
Notified Body number
0123
Internal PECP dossier #
In vitro diagnostic medical device
Chemiluminescent microparticle immunoassay (CMIA) used
for the qualitative detection of IgM antibodies to SARS-CoV-
2 in human serum and plasma
Intended purpose
P1
what is detected and/or measured
please specify the analyte(s) or marker(s), e.g. SARS-CoV-2 spike protein, Kel1 (K)
- Determination of IgM antibodies to SARS-CoV-2
P2
function of the device
e.g. diagnosis, aid to diagnosis, monitoring, determining the infectious load, tissue typing etc
Aid in the diagnosis of SARS CoV-2
infection
P3
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.
Exposure to SARS-CoV-2
P4
whether it is automated or not
Automated
P5
whether it is qualitative, semi-quantitative or
quantitative
Qualitative
P6
type of specimen(s)
e.g. whole blood, serum, saliva etc
Human serum and plasma
P7
where applicable, the testing population
e.g. persons with specific health conditions,
persons with specific symptoms, children in a
certain age range
Individuals who are suspected to have had coronavirus disease (COVID-19) or individuals that may have been infected by SARSCoV-2
P8
intended user
For Laboratory Professional Use
Only
Technology
T1
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.
Chemiluminescent microparticle
immunoassay (CMIA) technology