OVQ · Class II · 21 CFR 866.6040

FDA Product Code OVQ: Chronic Lymphocytic Leukemia Fish Probe Kit

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.

2
Total
2
Cleared
378d
Avg days
1997
Since

FDA 510(k) Cleared Chronic Lymphocytic Leukemia Fish Probe Kit Devices (Product Code OVQ)

2 devices
1–2 of 2
No devices found for this product code.

About Product Code OVQ - Regulatory Context