XA 13/21

Aneusomy Probe

Order Number
D-5602-100-OG
Package Size
100 µl (10 Tests)
Labels
  
Chromosomes
1321
Regulatory Status
IVDR

IVDR Certification

This probe is IVDR-certified in compliance with the Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). For organizational reasons, we currently provide only the IVDD product.

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Intended Purpose

The XA 13/21 enumeration probe is a qualitative, non-automated test for the detection of copy number variations of chromosome 13 and chromosome 21 by fluorescence in situ hybridization (FISH). The product is intended for prenatal testing of pregnancies at risk for trisomy 13 and trisomy 21 on methanol/acetic-acid fixed uncultured amniocytes.

Product Description

The XA 13/21 enumeration probe consists of a green-labeled probe hybridizing to the RB1 gene region at 13q14.2 and an orange-labeled probe hybridizing to the DSCR4 gene region at 21q22.1-22.2.

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Images

XA 13/21

XA 13/21 was hybridized to normal lymphocytes. Interphase nuclei with two orange and two green signals each are shown.

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Expected Patterns

Expected Pattern 1

Normal Cell:
Two green (2G), two orange (2O) signals.

Expected Pattern 2

Aberrant Cell:
Three green (3G) and two orange (2O) signals.

Expected Pattern 3

Aberrant Cell:
Two green (2G) and three orange (3O) signals.

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Downloads

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