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.

Leading manufacturers include Abbott Molecular, Inc. and Vysis.

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
Cleared Aug 09, 2011
VYSIS CLL FISH PROBE KIT (VYSIS LSI TP53 SPECTRUMORANGE/ATM SPECTRUMGREEN) AND LSI D135319 SPECTRUMORANGE/13Q34
K100015
Abbott Molecular, Inc.
Pathology · 582d
Cleared Jan 13, 1997
CEP 12 SPECTRUMORANGE DIRECT LABELED CHROMOSOME ENUMERATION DNA PROBE
K962873
Vysis
Pathology · 174d

About Product Code OVQ - Regulatory Context