PDO

Early Growth Response Gene 1 (Egr1) Fish Probe Kit For Specimen Characterization

Product code

PDO

Device name

Early Growth Response Gene 1 (Egr1) Fish Probe Kit For Specimen Characterization

Device class

Class 2

21 CFR

21 CFR 864.1870

Medical specialty

Hematology

Marketing pathway

510(K)

Flag

Third-party review eligible

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).