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 CCND1
Break Apart Probe
- Order Number
- D-5071-100-OG
- Package Size
- 100 µl (10 Tests)
- Chromosome
- 1111
- 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 CCND1 consists of an orange-labeled probe hybridizing proximal to the MYEOV gene region at 11q13.3 and a green-labeled probe hybridizing to CCND1 and distal to the CCND1 gene region at 11q13.3.
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
- Multiple Myeloma and Plasma Cell Neoplasms (MM)
- Non-Hodgkin Lymphomas (NHL)
- Chronic Lymphocytic Leukemia (CLL)
XL CCND1 hybridized to lymphocytes. One normal metaphase and two normal interphases are shown.
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.
- Vandraager et al (1997) Blood 89:349-350
- Fonseca et al (2002) Blood 99:3735-3741
- Wlodarska et al (2004) Leukemia 18:1705-1710
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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