OVQ
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Chronic Lymphocytic Leukemia Fish Probe Kit
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.6040
- Medical specialty
- Immunology
- Flags
- Third-party review eligible
- FDA 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.
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| Record | Firm | Date |
|---|---|---|
| VYSIS CLL FISH PROBE KIT (VYSIS LSI TP53 SPECTRUMORANGE/ATM SPECTRUMGREEN) AND LSI D135319 SPECTRUMORANGE/13Q34 (K100015) | Abbott Molecular, Inc. | 2011-08-09 |
| CEP 12 SPECTRUMORANGE DIRECT LABELED CHROMOSOME ENUMERATION DNA PROBE (K962873) | Vysis | 1997-01-13 |
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