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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 gene 1 (egr1) fish probe kit for specimen characterization
Regulation Description Early growth response 1 (EGR1) gene fluorescence in-situ hybridization (FISH) test system for specimen characterization.
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.
Product CodePDO
Regulation Number 864.1870
Device Class 2