LeukoStrat CDx FLT3 Mutation Assay

Primary DI

00810022732557

Basic UDI-DI Code

081002273K41204314J

Reference

K4120431

Device Types

None provided

Regulation

Eu Ivdr

Classification

Eu Ivd Class C

Status

No Longer On The Market

Manufacturer

Invivoscribe, Inc.

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). The LeukoStrat CDx FLT3 Mutation Assay may be used as a companion diagnostic for the following therapeutic: In regions where XOSPATA® (gilteritinib fumarate) is available, the LeukoStrat CDx FLT3 Mutation Assay is used as an aid in the assessment of patients with AML for whom XOSPATA® (gilteritinib fumarate) treatment is being considered. The qualitative, non-automated test is for use on the 3500xL or 3500xL Dx Genetic Analyzers.

The Basic UDI-DI associated with this device has 2 devices in total. Below are some other devices sharing the same Basic UDI-DI.

Other on-the-market devices with the same classification (Eu Ivd Class C) and regulation (EU IVDR).