Genomadix Cube CYP2C19

Basic Information

• Brand Name: Genomadix Cube CYP2C19
• Primary DI: G257ASM000990
• 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: df87262a-f8da-44fb-8aca-da403f03475d

Device Description

Genomadix Cube CYP2C19 System, Control Kit, Cartridges. Box of 10 controls, reagents.

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	G257ASM000990	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.