FDA.reportPublic FDA data

Genomadix Cube CYP2C19

Primary DI
G257ASM000990
Brand
Genomadix Cube CYP2C19
Company
Genomadix Inc
Model
2
Device description
Genomadix Cube CYP2C19 System, Control Kit, Cartridges. Box of 10 controls, reagents.
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
G257ASM000990PrimaryHIBCC0

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
G257ASM001010Genomadix 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
G257ASM001010Genomadix 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