MetaSystems Probes has received IVDR certification for our XCyting FISH probes for prenatal aneusomy testing – the XA aneusomy probes.
XA 13/21
Aneusomy Probe
- Order Number
- D-5602-100-OG
- Package Size
- 100 µl (10 Tests)
- 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 XA 13/21 enumeration probe consists of a green-labeled probe hybridizing to the RB1 gene region at 13q14.2 and an orange-labeled probe hybridizing to the DSCR4 gene region at 21q22.1-22.2.
Normal Cell:
Two green (2G), two orange (2O) signals.
Aberrant Cell:
Three green (3G) and two orange (2O) signals.
Aberrant Cell:
Two green (2G) and three orange (3O) signals.
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.