Anti-SARS-CoV-2 Antibody Detection
Date of reception of the dossier
Notified Body number
Internal PECP dossier #
In vitro diagnostic medical device
The device is a qualitative double-antigen sandwich assay for
the detection of Antibodies to SARS-CoV-2 in serum/plasma.
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
Aid in the determination of the
immune reaction to SARS-CoV-2.
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.
Severe Acute Respiratory Syndrome
Coronavirus 2 (SARS-CoV-2)
whether it is automated or not
whether it is qualitative, semi-quantitative or
type of specimen(s)
e.g. whole blood, serum, saliva etc
Serum, venous plasma
where applicable, the testing population
e.g. persons with specific health conditions,
persons with specific symptoms, children in a
certain age range
No specific testing population
Professional Laboratory User
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.
Double-antigen sandwich assay
detection method (ECLIA)