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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
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


Premarket Reviews
ManufacturerDecision
ABBOTT MOLECULAR, INC.
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