FDA.reportPublic FDA data

Genomadix Cube CYP2C19

Primary DI
G257ASM000960
Brand
Genomadix Cube CYP2C19
Company
Genomadix Inc
Model
2
Device description
This contains the laptop, cube, power adapter and cables.
Published
2024-06-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
G257ASM000960PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Thermal cycler nucleic acid amplification analyser IVD, laboratoryAn electrically-powered automated or semi-automated laboratory instrument intended to amplify target deoxyribonucleic acid (DNA) or ribonucleic acid (RNA) in a clinical specimen using heat-stable polymerase enzymes and cycles of repeated heating and cooling (i.e., thermal cycling) to replicate a product [i.e., a polymerase chain reaction (PCR)]. Amplified product is detected and/or identified using oligonucleotide markers as it is produced (i.e., in real-time) or at the end-point. The analyser may also isolate, extract and/or prepare nucleic acid from the clinical specimen and/or culture isolate prior to amplification.

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
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G257ASM000990Genomadix 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
G257ASM000990Genomadix 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