Fetal RHD status

Date of reception of the dossier

Ongoing performance evaluation

Notified Body number

Internal PECP dossier #

In vitro diagnostic medical device

Test to decide if a prepartum anti-D prophylaxis should be administered to RhD-negative pregnant women

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.

RHD status of the fetus, as a RhD-positive fetus causes the formation of anti-D IgG antibodies in an RhD-negative mother


whether it is automated or not

Non-automated assay


whether it is qualitative, semi-quantitative or

Qualitative assay


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

Extracted human maternal plasma


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

Non-immunized RhD-negative pregnant women


intended user

For Professional Use Only (trained users)



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.

Real-time polymerase chain reaction (PCR) – amplification of the specific Target Sequence using fluorescence-labelled oligonucleotide probes

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