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XA 21q22
Aneusomy Probe
- Order Number
- D-5601-100-OR
- Package Size
- 100 µl (10 Tests)
- Labels
- orange
- Chromosome
- 2121
- 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 21q22 enumeration probe is a qualitative, non-automated test for the detection of copy number variations of chromosome 21 by fluorescence in situ hybridization (FISH). The product is intended for prenatal testing of pregnancies at risk for trisomy 21 on methanol/acetic-acid fixed uncultured amniocytes.
The XA 21q22 enumeration probe consists of 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 21q22 was hybridized to normal lymphocytes. A metaphase is shown with orange signals hybridized to 21q22.
Normal Cell:
Two orange (2O) signals.
Aberrant Cell:
Three orange (3O) signals.
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