MetaSystems Probes has received IVDR certification for our XCyting FISH probes for prenatal aneusomy testing – the XA aneusomy probes.
XL TP53/NF1
Deletion/Isochromosome Probe
- Order Number
- D-5089-100-OG
- Package Size
- 100 µl (10 Tests)
- Chromosome
- 1717
- 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 TP53/NF1 probe consists of an orange-labeled probe hybridizing to the TP53 gene region at 17p13 and a green-labeled probe hybridizing to the NF1 gene region at 17q11.2.
Normal Cell:
Two green (2G) and two orange (2O) signals.
Aberrant Cell (typical results):
Two green (2G) and one orange (1O) signal resulting from loss of one orange signal.
Aberrant Cell (typical results):
One green (1G) and one orange (1O) signal resulting from loss of one green and one orange signal.
Aberrant Cell (typical results):
Three green (3G) and one orange (1O) signal resulting from the presence of an isochromsome.
Aberrant Cell (typical results):
One green (1G) and two orange (2O) signal 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.