Early Growth Response Gene 1 (Egr1) Fish Probe Kit For Specimen Characterization
- US Product Code (FDA)
- PDOView Product Code Classification →
- US Risk Class (FDA)
- Class 2
- US Regulation (CFR)
- 21 CFR 864.1870View CFR Regulation →
- Medical specialty
- Hematology
- GMP exempt
- No
- Implantable
- No
- Life-sustaining
- No
- Third party review
- Eligible
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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Early Growth Response Gene 1 (Egr1) Fish Probe Kit For Specimen Characterization is a medical device type in the Hematology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.
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