PDO
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Early Growth Response Gene 1 (Egr1) Fish Probe Kit For Specimen Characterization
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.1870
- Medical specialty
- Hematology
- Flags
- Third-party review eligible
- FDA definition
- The EGR1 FISH Probe Kit for specimen characterization detects the LSI EGR1 probe target on chromosome 5q in bone marrow specimens. This assay is used to characterize bone marrow specimens from patients with acute myeloid leukemia (AML) or myelodysplastic syndrome. The assay results are to be interpreted by a qualified pathologist or cytogeneticist.
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| Record | Firm | Date |
|---|---|---|
| VYSIS EGR1 FISH PROBE KIT - SC (SPECIMEN CHARACTERIZATION) (DEN130010) | Abbott Molecular, Inc. | 2013-07-29 |
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