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This probe is IVDR-certified in compliance with the Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). For organizational reasons, we currently provide only the IVDD product.
The XL CDKN2A probe consists of an orange-labeled probe hybridizing to the CDKN2A (p16)/CDKN2B (p15) gene region at 9p21 and a green-labeled probe hybridizing to the centromere of chromosome 9.
XL CDKN2A hybridized to bone marrow cells. Two normal cells and several cells with two green signals are shown indicating a homozygous deletion of the CDKN2A.
Normal Cell:
Two green (2G) and two orange (2O) signals.
Aberrant Cell (typical results):
Two green (2G) and one orange (1O) signal resulting from loss of one orange signal.
Aberrant Cell (typical results):
Two green (2G) and no orange
(no O) signal resulting from homozygous deletion of the locus covered by the orange probe.
MetaSystems Probes has received IVDR certification for our initial 26 fluorescence in situ hybridization (FISH) probes from the notified body, BSI. Achieving this milestone was not without its challenges, and we are delighted to have accomplished IVDR certification for this probe set at an early stage.
The IVDR is effective and our probes stay the same! A large segment of our portfolio is already IVDR-certified. Our priority is to give you a smooth transition into the IVDR era.
We hope you had a chance to meet us.
