# Early Growth Response Gene 1 (Egr1) Fish Probe Kit For Specimen Characterization
> **Product code: PDO** · Class II — Moderate Risk (510(k) clearance required) · Hematology · 21 CFR 864.1870
## Classification
- **FDA Product Code:** PDO
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 864.1870
- **Review panel:** PA
- **Medical specialty:** Hematology
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** Y
## 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.

## Market data
- **Cleared 510(k) submissions:** 1
- **Registered establishments:** 2
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=PDO)
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