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Chronic Lymphocytic Leukemia Fish Probe Kit

FDA product code OVQ · 2 cleared devices

Class 2 Immunology
Regulation
21 CFR 866.6040
Review panel
PA
Implant
No
Life sustaining
No
Third party review
Yes
GMP exempt
No
Clearance span
1997-01-13 – 2011-08-09

The CLL FISH Probe Kit is intended to detect deletion of the LSI TP53, LSI ATM, and LSI D13S319 probe targets and gain of the D12Z3 sequence in peripheral blood specimens from untreated patients with B-cell chronic lymphocytic leukemia (CLL). The assay may be used to dichotomize CLL (the 13q-, +12, or normal genotype group versus the 11q- or 17p- group) and may be used as an aid in determining disease prognosis in combination with additional biomarkers, morphology and other clinical information.

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