FDA.reportPublic FDA data

GENOMADIX INC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30210476483021047648GENOMADIX INC1N2026-01-01340 Legget Drive Suite 180 Kanata (Ottawa) Ontario CA K2K1Y6

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
ASM00101Genomadix Cube CYP2C19, - Genomadix Cube CYP2C19 System, Test Kit, Cartridges: Contains substances for DNA extraction, PCR amplification, and detection of the CYP2C19 alleles, in three separate tubes. Each tube is specific for the detection of one of the three CYP2C19 loci. One box of Test Kit, cartridges contains 20 cartridges; one cartridge per pouch.The Genomadix Cube CYP2C19 Test is indicated for use with the Genomadix Cube CYP2C19 Platform.18772287756support@genomadix.com
ASM00101Genomadix Cube CYP2C19, - Genomadix Cube CYP2C19 System, Test Kit, Cartridges: Contains substances for DNA extraction, PCR amplification, and detection of the CYP2C19 alleles, in three separate tubes. Each tube is specific for the detection of one of the three CYP2C19 loci. One box of Test Kit, cartridges contains 20 cartridges; one cartridge per pouch.The Genomadix Cube CYP2C19 Test is indicated for use with the Genomadix Cube CYP2C19 Platform.1-888-810-7788support@genomadix.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3197172035261322K220026Genomadix Cube CYP2C19 SystemNTI2023-03-21

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NTI12023-03-21

PMN#

GUDID#