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 AneuScore II
Aneusomy Probe
- Order Number
- D-5609-100-TC
- Package Size
- (2x 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 13/18/21 enumeration probe is a qualitative, non-automated test for the detection of copy number variations of chromosome 13, chromosome 18 and chromosome 21 by fluorescence in situ hybridization (FISH). The XA X/Y enumeration probe is a qualitative, non-automated test for the detection of copy number variations of chromosome X and chromosome Y by fluorescence in situ hybridization (FISH). The products are intended for prenatal testing of pregnancies at risk for copy number variations of chromosomes X and chromosome Y and trisomy 13, trisomy 18 and trisomy 21 on methanol/acetic-acid fixed uncultured amniocytes.
The XA AneuScore II contains different probe mixes provided in separate test vials.
XA 13/18/21 (D-5607-100-TC):
The XA 13/18/21 enumeration probe consists of a green-labeled probe hybridizing to the RB1 gene region at 13q14.2, an aqua-labeled probe hybridizing to the MALT1 gene region at 18q21.3 and an orange-labeled probe hybridizing to the DSCR4 gene region at 21q22.1-22.2.
XA X/Y (D-5608-100-OG):
The XA X/Y enumeration probe consists of a green-labeled probe hybridizing to the centromere of the X-chromosome and an orange-labeled probe hybridizing to the centromere of the Y-chromosome.
XA 13/18/21 and XA X/Y hybridized to uncultured amniocytes. One interphase and one metaphase are shown for each probe mix.
For signal patterns please refer to: XA 13/18/21 (D-5607-100-TC) and XA X/Y (D-5608-100-OG).
Probes Catalog
Certificate of Analysis (CoA)
or go to CoA DatabaseIVDR 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.
