Chronic Lymphocytic Leukemia Fish Probe Kit
Device Code: 2464
Product Code(s):
OVQ 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 Ass
Device Classification Information
| Device Type ID | 2464 |
| Device Name | Chronic Lymphocytic Leukemia Fish Probe Kit |
| Physical State | Reagents For B-cell Chronic Lymphocytic Leukemia Prognosis |
| Technical Method | Fluorescent In Situ Hybridization |
| Target Area | B-cell Chronic Lymphocytic Leukemia |
| Regulation Description | Gene Expression Profiling Test System For Breast Cancer Prognosis. |
| Regulation Medical Specialty | Immunology |
| Review Panel | Hematology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR)
|
| Submission Type | 510(k) |
| CFR Regulation Number | 866.6040 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OVQ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
Recognized Standards
Total Product Life Cycle
| Device Type ID | 2464 |
| Device | Chronic Lymphocytic Leukemia Fish Probe Kit |
| Product Code | OVQ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Gene Expression Profiling Test System For Breast Cancer Prognosis. |
| CFR Regulation Number | 866.6040 [🔎] |
TPLC Last Update: 2019-04-02 20:12:51