OWK

Early Growth Response 1 (Egr) Fish Probe Kit

Product code

OWK

Device name

Early Growth Response 1 (Egr) Fish Probe Kit

Device class

Class 2

21 CFR

21 CFR 866.6040

Medical specialty

Immunology

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 is intended to detect deletion of the lsi egr1 probe target in bone marrow specimens and may be used, in addition to cytogenetics, other biomarkers, morphology, and other clinical information, at the time of diagnosis as an aid in determining the prognosis of acute myeloid leukemia (aml) patients.

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