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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 MDM2 enumeration probe consists of an orange-labeled probe hybridizing to the MDM2 gene region at 12q15 and a green-labeled probe hybridizing to the centromere of chromosome 12.
XL MDM2 hybridized to lymphocytes. Two normal interphases and one normal metaphase are shown.
Normal Cell:
Two green (2G) and two orange (2O) signals.
Aberrant Cell (typical results):
Two green (2G) and three orange (3O) signals resulting from gain of one orange signal.
Aberrant Cell (typical results):
Three green (3G) and three orange (3O) signals each resulting from a gain of one green signal and one orange signal.
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.
