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 TET2
Deletion Probe
- Order Number
- D-5038-100-OG
- Package Size
- 100 µl (10 Tests)
- Chromosome
- 044
- 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 TET2 consists of an orange-labeled probe hybridizing to the TET2 gene region at 4q24 and a green-labeled probe hybridizing to 4q12.
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
- Myelodysplastic Syndrome (MDS)
- Acute Myelogenous Leukemia (AML)
- Chronic Myelogenous Leukemia (CML)
XL TET2 hybridized to lymphocytes. One partial normal metaphase and two normal interphases are shown.
Normal Cell:
Two green (2G) and two orange (2O) signals.
Aberrant Cell (typical results):
Two green (2G) and one orange (1O) signal resulting from loss of one orange signal.
- Jankowska et al (2009) Blood 113:6403-6410
- Delhommeau et al (2009) N Engl J Med 360:2289-2301
- Flach et al (2010) Haematologica 95:518-519
Package Insert (EN)Package Insert ( F)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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