MetaSystems Probes has received IVDR certification for our XCyting FISH probes for prenatal aneusomy testing – the XA aneusomy probes.
XCE pan-cen
XCyting Centromere Enumeration Probe
- Order Number
- D-0836-050-OR
- Package Size
- (5 Tests)
- Labels
- orange
- Chromosome
- AllAll
- 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 productsXCE pan-cen is composed of orange labeled repetitive sequences specific for human centromeres except for chromosome 1 which is identified by repetitive sequences specific for the heterochromatic region 1q12. The product is also available labeled in green (D-0836-050-FI).
The probe map is shown with green labeling, D-0836-050-OR is labeled in orange.
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.
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.