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XL CLL Probe Kit (XL DLEU/LAMP/12cen + XL ATM/TP53)
Deletion/Enumeration Probe
- Order Number
- D-5044-100-TC
- Package Size
- 2x 100 µl (2x 10 Tests)
- Regulatory Status
- IVDD
IVDR Certification
This probe is IVDR-certified in compliance with the Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR).
MetaSystems Probes has already certified a wide range of FISH probes, according to IVDR.
This product remains IVDD-certified until further notice.
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XL CLL contains different probe mixes provided in separate test vials.
XL DLEU/LAMP/12cen consists of a green-labeled probe hybridizing to the centromere of chromosome 12, an orange-labeled probe hybridizing to the DLEU1/MIR15A/MIR16-1 gene region at 13q14.2 including D13S319 and an aqua-labeled probe hybridizing to the LAMP1 gene region at 13q34.
XL ATM/TP53 consists of a green-labeled probe hybridizing to the ATM gene region at 11q22.3 and an orange-labeled probe hybridizing to the TP53 gene region at 17p13.
Probe maps for selected products have been updated. These updates ensure a consistent presentation of all gaps larger than 10 kb including adjustments to markers, genes, and related elements. This update does not affect the device characteristics or product composition. Please refer to the list to find out which products now include updated probe maps.
Probe map details are based on UCSC Genome Browser GRCh37/hg19, with map components not to scale.
The XL CLL Probe Kit is a combination of probes covering the most frequent chromosomal aberrations in chronic lymphocytic leukemia (CLL). For a more detailed description, please refer to product XL DLEU/LAMP/12cen (D-5055-100-TC) and XL ATM/TP53 (D-5046-100-OG).
Clinical Applications
- Chronic Lymphocytic Leukemia (CLL)
- Multiple Myeloma and Plasma Cell Neoplasms (MM)
- Doehner et al (2000) N Engl J Med 343:1910-1916
- DeWald et al (2003) Brit J Haem 121:287-295
- Nelson et al (2007) Am J Clin Pathol 128:323-332
Certificate of Analysis (CoA)
or go to CoA Database