LeukoStrat

GUDID 00850052003685

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.

INVIVOSCRIBE, INC.

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

• Primary Device ID: 00850052003685
• NIH Device Record Key: e6f5c5a3-99f5-4767-8c95-59a3a49afb0e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LeukoStrat
• Version Model Number: K4120221
• Company DUNS: 836976779
• Company Name: INVIVOSCRIBE, INC.
• Device Count: 1
• DM Exempt: false
• 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	00850052003685 [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: 2020-06-08
• Device Publish Date: 2020-05-29

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