Genomadix Cube CYP2C19

Basic Information

• Brand Name: Genomadix Cube CYP2C19
• Primary DI: G257ASM001010
• Version / Model: 2
• Company Name: Genomadix Inc
• Labeler DUNS: 204354752
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-06-14
• Public Version: 3
• Public Version Date: 2025-04-18
• Public Version Status: Update
• Public Device Record Key: 4ca632ce-988a-47a1-9b39-d6febdd24e7b

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

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NTI	Drug Metabolizing Enzyme Genotyping Systems	Clinical Toxicology	862.3360	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60091	Nucleic acid amplification mastermix kit IVD	A collection of reagents and other associated materials [enzymes, buffers, nucleotides, magnesium chloride (MgCl2)], intended to be used in combination with sequence-specific primers, probes and/or controls (not included) 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)].	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	G257ASM001010	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K220026	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -80 – -15 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Shipping box contains dry ice.