LeukoStrat K4120361

GUDID 00810022732571

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).

INVIVOSCRIBE, INC.

Acute myeloid leukaemia (AML) genetic mutation IVD, kit, nucleic acid technique (NAT)

• Primary Device ID: 00810022732571
• NIH Device Record Key: b3e2403b-7a59-40cf-a459-48ed2ae58ea5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LeukoStrat
• Version Model Number: 00810022732571
• Catalog Number: K4120361
• Company DUNS: 836976779
• Company Name: INVIVOSCRIBE, INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810022732571 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P160040

FDA Product Code

• OWD: Somatic Gene Mutation Detection System

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-07
• Device Publish Date: 2023-05-30

On-Brand Devices [LeukoStrat]

• 00850052003685: The LeukoStrat CDx FLT3 Mutation Assay targets regions of the FLT3 gene to identify internal tan
• 00850052003739: The LeukoStrat CDx FLT3 Mutation Assay is a PCR-based in vitro diagnostic test designed to detec
• 00810022732571: The LeukoStrat CDx FLT3 Mutation Assay is a PCR-based in vitro diagnostic test designed to detec