FDA.reportPublic FDA data

Genomadix Cube CYP2C19

Primary DI
G257ASM001010
Brand
Genomadix Cube CYP2C19
Company
Genomadix Inc
Model
2
Device description
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
Published
2024-06-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NTIDrug Metabolizing Enzyme Genotyping Systems

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NTIDrug Metabolizing Enzyme Genotyping SystemsClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K220026000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220026000Genomadix Cube CYP2C19 SystemGenomadix, Inc.2023-03-21NTI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G257ASM001010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Nucleic acid amplification mastermix kit IVDA collection of reagents and other associated materials intended to be used in combination with sequence-specific primers, probes and/or controls to facilitate the amplification of a target nucleic acid sequence [i.e., deoxyribonucleic acid (DNA) or ribonucleic acid (RNA)} in a clinical specimen, using a nucleic acid amplification technique (e.g., polymerase chain reaction (PCR), loop-mediated isothermal amplification (LAMP)].

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Shipping box contains dry ice.
Storage Environment Temperature-80 Degrees Celsius-15 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
18772287756support@genomadix.com
1-888-810-7788support@genomadix.com

Regulatory Flags#

DUNS number
204354752
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G257ASM000960Genomadix Cube CYP2C1922024-06-14
G257ASM000990Genomadix Cube CYP2C1922024-06-14
G257ASM001160Genomadix Cube CYP2C1922024-06-14
ASM00101Genomadix Cube CYP2C19,22023-07-18
G257ASM001030Genomadix Cube CYP2C1922024-06-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G257ASM000960Genomadix Cube CYP2C19Genomadix IncNTI2024-06-14
G257ASM000990Genomadix Cube CYP2C19Genomadix IncNTI2024-06-14
G257ASM001030Genomadix Cube CYP2C19Genomadix IncNTI2024-06-14
G257ASM001160Genomadix Cube CYP2C19Genomadix IncNTI2024-06-14
ASM00101Genomadix Cube CYP2C19,Genomadix IncNTI2023-07-18
00850009370136INFINITI® CYP2C19 BioFilmChip® Microarray MagazineAUTOGENOMICS, INCNTI2019-10-23
00850009370143INFINITI® CYP2C19 Intellipac® Reagent ModuleAUTOGENOMICS, INCNTI2019-10-23
00850009370150INFINITI® CYP2C19 Amplification MixAUTOGENOMICS, INCNTI2019-10-23
00628055420019Spartan RX CYP2C19 SystemSpartan Bioscience IncNTI2016-09-26
00628055420026Spartan RX CYP2C19 SystemSpartan Bioscience IncNTI2016-09-26
00628055420033Spartan RX CYP2C19 SystemSpartan Bioscience IncNTI2016-09-26
00628055420040Spartan RX CYP2C19 SystemSpartan Bioscience IncNTI2016-09-26
00628055420057Spartan RX CYP2C19 SystemSpartan Bioscience IncNTI2016-09-26
00628055420064Spartan RX CYP2C19 SystemSpartan Bioscience IncNTI2016-09-26
00628055420071Spartan RX CYP2C19 SystemSpartan Bioscience IncNTI2016-09-26
00628055420088Spartan RX CYP2C19 SystemSpartan Bioscience IncNTI2016-09-26
00628055420095Spartan RX CYP2C19 SystemSpartan Bioscience IncNTI2016-09-26
00628055420101Spartan RX CYP2C19 SystemSpartan Bioscience IncNTI2016-09-26
00840487100134xTAG® CYP2D6 Kit v3Luminex Molecular Diagnostics, IncNTI2016-09-09
00840487100172xTAG® CYP2C19 Kit v3Luminex Molecular Diagnostics, IncNTI2016-09-09
00840487101025xTAG® CYP2D6 Kit v3Luminex Molecular Diagnostics, IncNTI2016-09-09