MetaSystems Probes has received IVDR certification for our XCyting FISH probes for prenatal aneusomy testing – the XA aneusomy probes.
Our Complete Set of XA Aneusomy Probes for Prenatal Testing Is IVDR Certified.
XA X/Y/18
Aneusomy Probe
- Order Number
- D-5606-100-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 on in vitro diagnostic medical devices (IVDR). For organizational reasons, we currently provide only the IVDD product.
The XA X/Y/18 enumeration probe is a qualitative, non-automated test for the detection of copy number variations of chromosome X, chromosome Y and chromosome 18 by fluorescence in situ hybridization (FISH). The product is intended for prenatal testing of pregnancies at risk for copy number variations of chromosomes X and chromosome Y and trisomy 18 on methanol/acetic-acid fixed uncultured amniocytes.
The XA X/Y/18 enumeration probe consists of a green-labeled probe hybridizing to the centromere of the X-chromosome, an orange-labeled probe hybridizing to the centromere of the Y-chromosome and an aqua-labeled probe hybridizing to the centromere of the chromosome 18.
XA X/Y/18 hybridized to normal uncultured amniocytes. A normal signal constellation with 1 orange (Y centromere-specific), 1 green (X centromere-specific) and 2 blue (18 centromere-specific) is observed.
Normal Cell (male):
One green (1G), one orange (1O), and two blue (2B) signals.
Normal Cell (female):
Two green (2G) and two blue (2B) signals.
Aberrant Cell (male):
One green (1G), one orange (1O), and three blue (3B) signals.
Aberrant Cell (female):
Two green (2G) and three blue (3B) signals.
Aberrant Cell (male):
Two green (2G), one orange (1O) and, two blue (2B) signals.
Aberrant Cell (female):
One green (1G) and two blue (2B) signals.
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.
Over 50 XCyting FISH Probes are IVDR-Certified!
The IVDR is effective and our probes stay the same! A large segment of our portfolio is already IVDR-certified. Our priority is to give you a smooth transition into the IVDR era.
