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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device chronic lymphocytic leukemia fish probe kit
Regulation Description Gene expression profiling test system for breast cancer prognosis.
Definition 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.
Product CodeOVQ
Regulation Number 866.6040
Device Class 2