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 4/10/17
XCyting Centromere Enumeration Probe
- Order Number
- D-0830-050-TC
- 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 4/10/17 DNA probe contains a mix of repetitive sequences specific for the chromosome 10 centromeric region in green, chromosome 4 centromeric region in orange, and chromosome 17 centromeric region in aqua.
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.
Clinical Applications
- Acute Lymphoblastic Leukemia (ALL)
XCE 4/10/17 was hybridized to normal lymphocytes.
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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