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.
XCP-Mix #1O-#2G-#4GO
XCyting Chromosome Paint
- Order Number
- D-0328-200-MC
- Package Size
- 200 µl (20 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
Probe mix containing whole chromosome paints (XCP) specific for chromosome 1 labeled with an orange emitting fluorophore, chromosome 2 with a green emitting fluorophore, and chromosome 4 with a combination of the 2 fluorophores.
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.
XCP-Mix #1O-#2G-#4GO hybridized to lymphocytes. One normal metaphase is shown. XCP1 orange, XCP2, green and XCP 4 yellow (green-orange).
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.
