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.
XCE X/Yqh
XCyting Centromere Enumeration Probe
- Order Number
- D-0832-050-OG
- Package Size
- 50 µl (5 Tests)
- 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
The XCE X/Yqh DNA probe contains a mix of repetitive sequences specific for the chromosome X centromeric region in orange and chromosome Yqh in green which is located in the heterochromatic region at Yq12.
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.
XCE X/Yqh hybridized to lymphocytes. One normal interphase and metaphase are shown.
Normal Cell Female:
46, XX
Two orange (2O) signals.
Normal Cell Male:
46, XY
One green (1G) and one orange (1O) signal.
Aberrant Cell Female:
Turner (45,X0)
One orange (1O) signal.
Aberrant Cell Male:
Klinefelter (47,XXY)
One green (1G) and two orange (2O) signals.
- Dewald et al (1993) Bone Marrow Trans 12:149-154
- Najfeld et al (1997) Bone Marrow Trans 19:829-834
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.
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