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.
XL CDKN2C/
CKS1B
Enumeration Probe
- Order Number
- D-5099-100-OG
- Package Size
- 100 µl (10 Tests)
- Chromosome
- 011
- 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 XL CDKN2C/CKS1B enumeration probe is a qualitative, non-automated test for the detection of copy number variations of the CDKN2C gene region at 1p32 and the CKS1B gene region at 1q21 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 multiple myeloma (MM). Hybridization is to be performed on methanol/acetic-acid fixed plasma cells.
The XL CDKN2C/CKS1B enumeration probe consists of a green-labeled probe hybridizing to the CDKN2C (p18) gene region at 1p32.3 and an orange-labeled probe hybridizing to the CKS1B gene region at 1q21-22.
XL CDKN2C/CKS1B hybridized to lymphocytes. Three normal interphases are shown.
Normal Cell:
Two green (2G) and two orange (2O) signals.
Aberrant Cell (typical results):
Two green (2G) and three orange (3O) signals resulting from gain of one orange signal.
Aberrant Cell (typical results):
One green (1G) and two orange (2O) signals resulting from loss of one green signal.
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.
Greetings from Nijmegen, NL
We hope you had a chance to meet us.
