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Early Growth Response 1 (Egr) Fish Probe Kit

FDA product code OWK · 1 cleared devices

Class 2 Immunology
Regulation
21 CFR 866.6040
Review panel
PA
Implant
No
Life sustaining
No
Third party review
Yes
GMP exempt
No
Clearance span
2011-08-29 – 2011-08-29

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.

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