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Invivoscribe, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30141730603014173060Invivoscribe, Inc.1N2026-01-0110222 Barnes Canyon Road, Building 1 San Diego CA US 92121

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2142181340000896P160040LeukoStrat CDx FLT3 Mutation AssayOWD2017-04-28
2142181285296458
2142181704638894

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
OWD12017-04-28

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...

GUDID#

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

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