XL 21q22 /
XCP 21

Order Number
D-5441-050-OG
Package Size
50 µl (5 Tests)
Labels
  
Chromosome
21
Regulatory Status
RUO

IVDR Certification

MetaSystems Probes has already certified a large part of its portfolio, according to IVDR. For organizational reasons, we currently provide only the IVDD product.

Discover all IVDR-certified products

Product Description

XL 21q22 /<br />XCP 21

The XL 21q22/XCP 21 is a combination of a whole chromosome paint 21 in green with an orange labeled locus-specific probe for 21q22. This probe allows analysis of copy numbers and structural aberrations of chromosome 21 on metaphase chromosomes.

XL 21q22/XCP 21 hybridized to normal human metaphase spreads will result in green signals along the entire length of chromosome 21 combined with orange signals at 21q22 (Down Syndrome Critical Region 4).

Please note that this product is not classified as an IVD product in the EU according to the REGULATION (EU) 2017/746 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU. It is marked as for ´Research Use Only´ (RUO).

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.

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Images

XL 21q22 /<br />XCP 21

XL 21q22/XCP21 was hybridized to normal lymphocytes. A metaphase with chromosomes 21 painted in green and orange signals at 21q22 is shown.

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News


IVDR 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.

IVDR Certification