Fish Based Detection Of Chromosomal Abnormalities From Patients With Hematologic Malignancies
Device Code: 4930
Product Code(s):
QDI Definition: Fluorescence In Situ Hybridization (FISH) Test For Hematologic Malignancies Is Used To Detect Chromosomal Abnormalities In Human Specimens From Patients With Hematologic Malignancies. The Test Is Indicated For The Clinical Management Of Patients Cons
Device Classification Information
| Device Type ID | 4930 |
| Device Name | Fish Based Detection Of Chromosomal Abnormalities From Patients With Hematologic Malignancies |
| Physical State | The Test Kits May Include Fluorescence Labeled DNA Probes, Hybridization Buffers, And A Counterstain |
| Technical Method | Fluorescence In Situ Hybridization |
| Target Area | Human Bone Marrow And Peripheral Blood Specimens |
| Regulation Medical Specialty | Molecular Genetics |
| Review Panel | Pathology |
| Submission Type | 510(k) |
| CFR Regulation Number | 864.1880 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | QDI |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
Recognized Standards
Total Product Life Cycle
| Device Type ID | 4930 |
| Device | Fish Based Detection Of Chromosomal Abnormalities From Patients With Hematologic Malignancies |
| Product Code | QDI |
| FDA Device Classification | Class 2 Medical Device |
| CFR Regulation Number | 864.1880 [🔎] |
TPLC Last Update: 2019-04-02 20:57:39