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XA 13/18/21
Aneusomy Probe
- Order Number
- D-5607-100-TC
- 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.
IVDDIVDRDiscover 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, Belgium, Croatia, Cyprus, Czech Republic, Estonia, France, Germany, Iceland, Italy, Kuwait, Lebanon, Liechtenstein, Luxembourg, Malta, Netherlands, New Zealand, Poland, Slovakia, Slovenia, South Africa, and Switzerland, with the list of countries continuously expanding.
The XA 13/18/21 enumeration probe is a qualitative, non-automated test for the detection of copy number variations of chromosome 13, chromosome 18 and chromosome 21 by fluorescence in situ hybridization (FISH). The product is intended for prenatal testing of pregnancies at risk for trisomy 13, trisomy 18 and trisomy 21 on methanol/acetic-acid fixed uncultured amniocytes.
The XA 13/18/21 enumeration probe consists of a green-labeled probe hybridizing to the RB1 gene region at 13q14.2, an aqua-labeled probe hybridizing to the MALT1 gene region at 18q21.3 and an orange-labeled probe hybridizing to the DSCR4 gene region at 21q22.1-22.2.
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.
XA 13/18/21 hybridized to cultured amniocytes. A normal signal constellation is observed for 13q14 and 21q22, two green and two orange signals, respectively. For the 18q21 locus-specific probe three blue signals are shown.
Normal Cell:
Two green (2G), two orange (2O), and two blue (2B) signals.
Aberrant Cell:
Three green (3G), two orange (2O), and two blue (2B) signals.
Aberrant Cell:
Two green (2G), three orange (3O), and two blue (2B) signals.
Aberrant Cell:
Two green (2G), two orange (2O), and three blue (3B) signals.
Tumour Genetics Symposium 2025
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