MetaSystems Probes has received IVDR certification for our XCyting FISH probes for prenatal aneusomy testing – the XA aneusomy probes.
Our Complete Set of XA Aneusomy Probes for Prenatal Testing Is IVDR Certified.
XL MDM2
Enumeration Probe
- Order Number
- D-5047-100-OG
- Package Size
- 100 µl (10 Tests)
- Chromosome
- 1212
- Regulatory Status
- IVDR
IVDR Certification
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 is a qualitative, non-automated test for the detection of copy number variations of the MDM2 gene region at 12q15 and of chromosome 12 by fluorescence in situ hybridization (FISH). The product is intended as a diagnostic aid and assists in disease monitoring. The test population consists of patients with confirmed or suspected chronic lymphocytic leukemia (CLL). Hybridization is to be performed on methanol/acetic-acid fixed cells derived from bone marrow or peripheral blood.
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.
IVDR Certification
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.
Greetings from Nijmegen, NL
We hope you had a chance to meet us.
