OVQClass II
Chronic Lymphocytic Leukemia Fish Probe Kit
Immunology · 21 CFR 866.6040
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.
MDR events2All time
Recalls1All time
Registered firms2Currently listed
510(k) clearances2All time
Recent MDR events
2 adverse event reports on file
Event type breakdown
Malfunction2
Most-reported manufacturers
Recalls
1 recall events for this product code
Registered firms
2 firms currently registered for this product code
510(k) clearances
2 clearances for this product code