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.
Human mBAND Probe
- Order Number
- Package Size
- (3 Tests)
- Regulatory Status
MetaSystems Probes has already certified a large part of its portfolio, according to IVDR.
For organizational reasons, we currently provide only the IVDD product.
The mBAND technique is based on a series of partial chromosome paints for sequential partially overlapping chromosome regions of a single chromosome. For labeling the same 5 fluorochromes as in the 24XCyte probe are used. The characteristic multicolor banding pattern of mBAND is generated by quantifying the fluorescence intensity ratios along the chromosome. These ratios are unique and visualized as band-specific pseudo colors. mBAND provides information that allows for a precise analysis of even highly complex inter- and intrachromosomal aberrations.
Please note that this product is not classified as an IVD product in the EU according to the REGULATION (EU) 2017/746 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU. It is marked as for ´Research Use Only´ (RUO).
- Chudoba I et al (1999) Cytogenet Cell Genet 84:156-160
- Johannes C et al (1999) Chromosome Res 7:625-633
- MacKinnon RN and Campbell LJ (2005) Cancer Genet Cytogenet 163:176-179