XA 21q22

Aneusomy Probe

Order Number: D-5601-100-OR

Package Size: 100 µl (10 Tests)

Labels: orange

Chromosome: 2121

Regulatory Status: IVDR

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.

Discover all IVDR-certified products Download Instructions For Use (IFU)

This product may not be available in all countries outside the European Union.

Intended Purpose

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.

Product Description

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.

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