FDA product code OWK

Early Growth Response 1 (Egr) Fish Probe Kit

Immunology·Class 2·21 CFR 866.6040
US regulatory classifications
US Product Code (FDA)
OWK
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 866.6040
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Medical specialty
Immunology
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Eligible
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.

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About this record

Early Growth Response 1 (Egr) Fish Probe Kit is a medical device type in the Immunology 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.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.