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Device Description : Analyte specific reagent targets the diversity and joining regions of the human Analyte specific reagent targets the diversity and joining regions of the human immunoglobulin heavy chain gene.
Device Class : 1
Duns Number: 836976779
Premarket Exempt : Yes
Prescription Use : No
Device Description : The LeukoStrat CDx FLT3 Mutation Assay targets regions of the FLT3 gene to ident The LeukoStrat CDx FLT3 Mutation Assay targets regions of the FLT3 gene to identify internal tandem duplication (ITD) mutations and tyrosine kinase domain (TKD) mutations, such as the D835 and I836 mutations. The LeukoStrat CDx FLT3 Mutation Assay includes reagents, equipment, software and procedures for isolating mononuclear cells and extracting DNA from patient specimens to determine if FLT3 mutations are present. DNA is amplified via PCR, TKD amplicon is enzymatically digested, and the amplicons are detected via capillary electrophoresis.
Device Class : 3
Duns Number: 836976779
Premarket Exempt : No
Prescription Use : Yes
Device Description : The LeukoStrat CDx FLT3 Mutation Assay is a PCR-based in vitro diagnostic test d The LeukoStrat CDx FLT3 Mutation Assay is a PCR-based in vitro diagnostic test designed to detect internal tandem duplication (ITD) and tyrosine kinase domain (TKD) mutations D835 and I836 in the FLT3 gene in genomic DNA extracted from mononuclear cells obtained from peripheral blood or bone marrow aspirates of patients diagnosed with acute myelogenous leukemia (AML).
Device Class : 3
Duns Number: 836976779
Premarket Exempt : No
Prescription Use : Yes