AccessGUDID - DEVICE: LeukoStrat (00850052003685)

GUDID

Device Identifier (DI) Information

Brand Name: LeukoStrat
Version or Model: 850052003685
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: K4120221
Company Name: INVIVOSCRIBE, INC.

Primary DI Number: 00850052003685
Issuing Agency: GS1
Commercial Distribution End Date: October 14, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 836976779 *Terms of Use

Device Description: 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 Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
60077	Acute myeloid leukaemia (AML) genetic mutation IVD, kit, nucleic acid technique (NAT)	A collection of reagents and other associated materials intended to be used to evaluate a clinical specimen to diagnose, monitor or predict acute myeloid leukaemia (AML) based on changes at the gene or chromosomal level which may include FLT3 gene mutations, NPM1 gene mutations, t(8;21), inv(16) and/or t(15;17), using a nucleic acid technique (NAT).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OWD	Somatic Gene Mutation Detection System

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P160040	004

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e6f5c5a3-99f5-4767-8c95-59a3a49afb0e
Public Version Date: January 16, 2023
Public Version Number: 4
DI Record Publish Date: May 29, 2020