Invivoscribe, Inc.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3014173060	3014173060	Invivoscribe, Inc.	1	N	2026-01-01	10222 Barnes Canyon Road, Building 1 San Diego CA US 92121

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
214218	1340000896	P160040	LeukoStrat CDx FLT3 Mutation Assay	OWD	2017-04-28
214218	1285296458
214218	1704638894

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
OWD	1	2017-04-28

PMA#

LeukoStrat CDx FLT3 Mutation Assay
2022-04-11
INVIVOSCRIBE TECHNOLOGIES, INC10222 Barnes Canyon Road, Building 1san Diego, CA 92121 PMA NumberP160040 Supplement NumberS010 Date Received03/15/2022 Decision Date04/11/2022 Product Code OWD Advisory Committee Pathology Supplement Type30-day Notice Supplem...
LeukoStrat CDx FLT3 Mutation Assay
2021-08-11
INVIVOSCRIBE TECHNOLOGIES, INC
LeukoStrat CDx FLT3 Mutation Assay
2021-08-05
INVIVOSCRIBE TECHNOLOGIES, INC
LeukoStrat CDx FLT3 Mutation Assay
2020-05-14
INVIVOSCRIBE TECHNOLOGIES, INC
LeukoStrat CDx FLT3 Mutation Assay
2018-12-21
INVIVOSCRIBE TECHNOLOGIES, INC
LeukoStrat CDx FLT3 Mutation Assay
2018-12-07
INVIVOSCRIBE TECHNOLOGIES, INC
LeukoStrat CDx FLT3 Mutation Assay
2018-11-28
INVIVOSCRIBE TECHNOLOGIES, INC
LeukoStrat CDx FLT3 Mutation Assay
2018-01-19
INVIVOSCRIBE TECHNOLOGIES, INC
LeukoStrat CDx FLT3 Mutation Assay
2017-04-28
INVIVOSCRIBE TECHNOLOGIES, INC

GUDID#

LeukoStrat - 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.
2023-05-30
LeukoStrat - 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.
2020-06-08
Invivoscribe - This product targets the human BCR/ABL fusion gene.
INVIVOSCRIBE, INC.
2021-02-02
Invivoscribe - This product targets the human BCR/ABL fusion gene.
INVIVOSCRIBE, INC.
2021-02-02
LeukoStrat - 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.
2020-05-29
Invivoscribe - This analyte specific reagent targets the ITD analyte within the human FLT3 gene.
INVIVOSCRIBE, INC.
2022-01-18
Invivoscribe - This analyte specific reagent targets the ITD analyte within the human FLT3 gene.
INVIVOSCRIBE, INC.
2022-01-18
Invivoscribe - This analyte specific reagent targets the ITD analyte within the human FLT3 gene.
INVIVOSCRIBE, INC.
2022-01-18
Invivoscribe - This analyte specific reagent targets the ITD analyte within the human FLT3 gene.
INVIVOSCRIBE, INC.
2022-01-18
Invivoscribe - This analyte specific reagent targets the ITD analyte within the human FLT3 gene.
INVIVOSCRIBE, INC.
2022-01-18
Invivoscribe - This analyte specific reagent targets the ITD analyte within the human FLT3 gene.
INVIVOSCRIBE, INC.
2022-01-18
Invivoscribe - This analyte specific reagent targets the ITD analyte within the human FLT3 gene.
INVIVOSCRIBE, INC.
2022-01-18
Invivoscribe - This analyte specific reagent targets the ITD analyte within the human FLT3 gene.
INVIVOSCRIBE, INC.
2022-01-18
Invivoscribe - This analyte specific reagent targets the ITD analyte within the human FLT3 gene.
INVIVOSCRIBE, INC.
2022-01-18
Invivoscribe - This analyte specific reagent targets the ITD analyte within the human FLT3 gene.
INVIVOSCRIBE, INC.
2022-01-18
Invivoscribe - This analyte specific reagent targets the ITD analyte within the human FLT3 gene.
INVIVOSCRIBE, INC.
2022-01-18
Invivoscribe - This analyte specific reagent targets the ITD analyte within the human FLT3 gene.
INVIVOSCRIBE, INC.
2022-01-18
Invivoscribe - This analyte specific reagent targets the ITD analyte within the human FLT3 gene.
INVIVOSCRIBE, INC.
2022-01-18
Invivoscribe - This analyte specific reagent targets the ITD analyte within the human FLT3 gene.
INVIVOSCRIBE, INC.
2022-01-18
Invivoscribe - This analyte specific reagent targets the ITD analyte within the human FLT3 gene.
INVIVOSCRIBE, INC.
2022-01-18
Invivoscribe - This analyte specific reagent targets the ITD analyte within the human FLT3 gene.
INVIVOSCRIBE, INC.
2022-01-18
Invivoscribe - This analyte specific reagent targets the ITD analyte within the human FLT3 gene.
INVIVOSCRIBE, INC.
2022-01-18
Invivoscribe - This analyte specific reagent targets the ITD analyte within the human FLT3 gene.
INVIVOSCRIBE, INC.
2022-01-18
Invivoscribe - This analyte specific reagent targets the ITD analyte within the human FLT3 gene.
INVIVOSCRIBE, INC.
2022-01-18
Invivoscribe - This analyte specific reagent targets the ITD analyte within the human FLT3 gene.
INVIVOSCRIBE, INC.
2022-01-18
Invivoscribe - This analyte specific reagent targets the ITD analyte within the human FLT3 gene.
INVIVOSCRIBE, INC.
2022-01-18
Invivoscribe - This analyte specific reagent targets the ITD analyte within the human FLT3 gene.
INVIVOSCRIBE, INC.
2022-01-18
Invivoscribe - This analyte specific reagent targets the ITD analyte within the human FLT3 gene.
INVIVOSCRIBE, INC.
2022-01-18
Invivoscribe - This analyte specific reagent targets the ITD analyte within the human FLT3 gene.
INVIVOSCRIBE, INC.
2022-01-18
Invivoscribe - This analyte specific reagent targets the ITD analyte within the human FLT3 gene.
INVIVOSCRIBE, INC.
2022-01-18
Invivoscribe - This analyte specific reagent targets the ITD analyte within the human FLT3 gene.
INVIVOSCRIBE, INC.
2022-01-18
Invivoscribe - This analyte specific reagent targets the ITD analyte within the human FLT3 gene.
INVIVOSCRIBE, INC.
2022-01-18
Invivoscribe - This analyte specific reagent targets the ITD analyte within the human FLT3 gene.
INVIVOSCRIBE, INC.
2022-01-18
Invivoscribe - This analyte specific reagent targets the ITD analyte within the human FLT3 gene.
INVIVOSCRIBE, INC.
2022-01-18
Invivoscribe - This analyte specific reagent targets the ITD analyte within the human FLT3 gene.
INVIVOSCRIBE, INC.
2022-01-18
Invivoscribe - This analyte specific reagent targets the ITD analyte within the human FLT3 gene.
INVIVOSCRIBE, INC.
2022-01-18
Invivoscribe - This analyte specific reagent targets the ITD analyte within the human FLT3 gene.
INVIVOSCRIBE, INC.
2022-01-18
Invivoscribe - This analyte specific reagent targets the ITD analyte within the human FLT3 gene.
INVIVOSCRIBE, INC.
2022-01-18
Invivoscribe - This analyte specific reagent targets the ITD analyte within the human FLT3 gene.
INVIVOSCRIBE, INC.
2022-01-18
Invivoscribe - This analyte specific reagent targets the ITD analyte within the human FLT3 gene.
INVIVOSCRIBE, INC.
2022-01-18

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