FDA.reportPublic FDA data

LeukoStrat

Primary DI
00810022732571
Brand
LeukoStrat
Company
INVIVOSCRIBE, INC.
Model
00810022732571
Catalog number
K4120361
Device description
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).
Published
2023-05-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
OWDSomatic Gene Mutation Detection System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OWDSomatic Gene Mutation Detection SystemUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P160040006

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P160040006LeukoStrat CDx FLT3 Mutation AssayInvivoscribe Technologies, Inc.2017-04-28OWD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810022732571PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810022732571008100227325718100227325710810022732571

GMDN Terms#

Term, Definition table
TermDefinition
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).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
836976779
Device count
1
DM exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850052003739LeukoStrat850052003739K41203612020-06-08
00810022730638Invivoscribe810022730638A31000302021-02-02
00810022730676Invivoscribe810022730676A31000812021-02-02
00850052003685LeukoStrat850052003685K41202212020-05-29
00810022730744Invivoscribe810022730744A41200092022-01-18
00810022730768Invivoscribe810022730768A41200192022-01-18
00810022730775Invivoscribe810022730775A41200292022-01-18
00810022730805Invivoscribe810022730805A41200392022-01-18
00810022730812Invivoscribe810022730812A41200492022-01-18
00810022730829Invivoscribe810022730829A41200592022-01-18
00810022730843Invivoscribe810022730843A41200692022-01-18
00810022730867Invivoscribe810022730867A41200792022-01-18
00810022730881Invivoscribe810022730881A41200892022-01-18
00810022730898Invivoscribe810022730898A41200992022-01-18
00810022730911Invivoscribe810022730911A41201192022-01-18
00810022730928Invivoscribe810022730928A41201292022-01-18
00810022730935Invivoscribe810022730935A41201392022-01-18
00810022730942Invivoscribe810022730942A41201492022-01-18
00810022730959Invivoscribe810022730959A41201592022-01-18
00810022730973Invivoscribe810022730973A41201792022-01-18

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Primary DI, Brand, Company table
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00054749005123i-STATABBOTT POINT OF CARE INC.OWD2020-07-01
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00054749005178i-STATABBOTT POINT OF CARE INC.OWD2020-07-01
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00054749005529i-STATABBOTT POINT OF CARE INC.OWD2020-07-01
04053228035725therascreen® BRAF RGQ PCR KitQIAGEN GmbHOWD2020-06-11
00850052003739LeukoStratINVIVOSCRIBE, INC.OWD2020-06-08
00850052003685LeukoStratINVIVOSCRIBE, INC.OWD2020-05-29
00054749005512i-STATABBOTT POINT OF CARE INC.OWD2020-05-01
00054749005093i-STATABBOTT POINT OF CARE INC.OWD2019-12-20
04053228034223therascreen® PIK3CA RGQ PCR KitQIAGEN GmbHOWD2019-06-05
04053228034094therascreen® FGFR RGQ RT-PCR KitQIAGEN GmbHOWD2019-04-29
00884999047792RealTimeABBOTT MOLECULAR INC.OWD2018-08-06
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00884999047044RealTimeABBOTT MOLECULAR INC.OWD2017-08-11
00884999047051RealTimeABBOTT MOLECULAR INC.OWD2017-08-11
03573026559823THxID™ BRAFBIOMERIEUX SAOWD2017-05-12
04053228002048therascreen® KRAS RGQ PCR KitQIAGEN GmbHOWD2017-01-04