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 8 Green
Centromere Enumeration Probe
- Order Number
- D-0808-050-FI
- Package Size
- 50 µl (5 Tests)
- Labels
- green
- Chromosome
- 088
- 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 XCE 8 enumeration probe is a qualitative, non-automated test for the detection of copy number variations of chromosome 8 by fluorescence in situ hybridization (FISH). The product is intended as a diagnostic aid and assists in disease monitoring. The test population consists of patients with confirmed or suspected acute myeloid leukemia (AML), chronic myelomonocytic leukemia (CMML), chronic myeloid leukemia and myeloproliferative neoplasms (CML/MPN), myelodysplastic neoplasms (MDS) and myelodysplastic/myeloproliferative neoplasms (MDS/MPN). Hybridization is to be performed on methanol/acetic-acid fixed cells derived from bone marrow or peripheral blood.
The XCE 8 green enumeration probe consists of a green-labeled probe hybridizing to centromeric DNA sequences of chromosome 8.
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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