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 BCL6 BA
Break Apart Probe
- Order Number
- D-6016-100-OG
- Package Size
- 100 µl (10 Tests)
- Chromosome
- 033
- Regulatory Status
- IVDD
IVDR Certification
This probe is IVDR-certified in compliance with the Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR).
MetaSystems Probes has already certified a large part of its portfolio, according to IVDR. For organizational reasons, we currently provide only the IVDD product.
XL BCL6 BA consists of a green-labeled probe hybridizing proximal to the BCL6 gene region at 3q27 and an orange-labeled probe hybridizing distal to the BCL6 gene region at 3q27-28.
Probe maps are created in accordance with the intended purpose of the product. Solid colored bars do not necessarily indicate that the probe fully covers the indicated genomic region. Therefore, caution is advised when interpreting results generated through off-label use. Probe map details based on UCSC Genome Browser GRCh37/hg19. Map components not to scale. Further information is available on request.
Clinical Applications
- Non-Hodgkin Lymphomas (NHL)
- Solid Tumors (Solid Tumors)
XL BCL6 BA hybridized to a positive case. The cell to the left shows one normal orange green fusion signal and one separated orange and green signal, indicating a break in BCL6.
Normal Cell:
Two green-orange colocalization/fusion signals (2GO).
Aberrant Cell (typical results):
One green-orange colocalization/fusion signal (1GO), one separate green (1G) and orange (1O) signal each resulting from a chromosome break in the respective locus.
- Butler et al (2002) Cancer Res 62:4089-4094
- Katzenberger et al (2004) Am J Pathol 165:481-490
- Iqbal et al (2007) Leukemia 21:2332-2343
Package Insert (EN)Package Insert (IT)Performance Data (English)Probes Catalog
Certificate of Analysis (CoA)
or go to CoA DatabaseIVDR 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.
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