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XL IGH/MAFB DF
Translocation/Dual Fusion Probe
- Order Number
- D-5146-100-OG
- Package Size
- 100 µl (10 Tests)
- Regulatory Status
- IVDR
IVDR Certification
This probe is IVDR-certified in compliance with the Regulation (EU) 2017/746 for in vitro diagnostic medical devices (IVDR).
MetaSystems Probes has already certified a wide range of FISH probes, according to IVDR.
Please use the switch to change to the IVDD product.
IVDRIVDDDiscover all IVDR-certified productsDownload Instructions For Use (IFU)Until further notice, we will continue to provide IVDD products in various countries.
As part of our phased rollout, the IVDR-certified probes are now available in Australia, Austria, Bangladesh, Belgium, Chile, Croatia, Cyprus, Czech Republic, Estonia, France, Germany, Hong Kong, Iceland, Iraq, Ireland, Italy, Jordan, Kuwait, Lebanon, Liechtenstein, Luxembourg, Malta, Nepal, Netherlands, New Zealand, Northern Ireland, Oman, Pakistan, Palestine, Philippines, Poland, Slovakia, Slovenia, South Africa, Switzerland, Ukraine, and United Arab Emirates with the list of countries continuously expanding.
Note: Our IVDR-certified XA probes are now available across all EU countries. For more details, please visit the individual product pages.
The XL IGH/MAFB DF dual-fusion probe is a qualitative, non-automated test for the detection of IGH::MAFB-rearrangements t(14;20)(q32.3;q12) 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 multiple myeloma (MM). Hybridization is to be performed on methanol/acetic-acid fixed plasma cells.
The XL IGH/MAFB DF dual-fusion probe consists of a green-labeled probe hybridizing to the IGH gene region at 14q32.3 and an orange-labeled probe hybridizing to the MAFB gene and flanking regions at 20q12.
Probe maps for selected products have been updated. These updates ensure a consistent presentation of all gaps larger than 10 kb including adjustments to markers, genes, and related elements. This update does not affect the device characteristics or product composition. Please refer to the list to find out which products now include updated probe maps.
Probe map details are based on UCSC Genome Browser GRCh37/hg19, with map components not to scale.
XL IGH/MAFB DF hybridized to bone marrow cells, one aberrant cell is shown. A translocation t(14;20) has occurred generating a signal pattern of two colocalization/fusion signals, one green and one orange signal.
Normal Cell:
Two green (2G) and two orange (2O) signals.
Aberrant Cell (typical results):
One green (1G), one orange (1O), and two green-orange colocalization/fusion signals (2GO) resulting from a reciprocal translocation between the relevant loci.
Tumour Genetics Symposium 2025
Past event in Germany from May 8 to May 10, 2025
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European Cytogenetics Conference
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