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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device early growth response 1 (egr) fish probe kit
Regulation Description Gene expression profiling test system for breast cancer prognosis.
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.
Product CodeOWK
Regulation Number 866.6040
Device Class 2