Genomadix Cube CYP2C19

GUDID G257ASM001160

Each unit is a box of 5 training kits (containing water).

Genomadix Inc

Nucleic acid amplification mastermix kit IVD Nucleic acid amplification mastermix kit IVD Nucleic acid amplification mastermix kit IVD Nucleic acid amplification mastermix kit IVD Nucleic acid amplification mastermix kit IVD Nucleic acid amplification mastermix kit IVD Nucleic acid amplification mastermix kit IVD Nucleic acid amplification mastermix kit IVD Nucleic acid amplification mastermix kit IVD Nucleic acid amplification mastermix kit IVD Nucleic acid amplification mastermix kit IVD Nucleic acid amplification mastermix kit IVD

• Primary Device ID: G257ASM001160
• NIH Device Record Key: c889c82f-0410-45bf-be13-e48878a59a1a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Genomadix Cube CYP2C19
• Version Model Number: 2
• Company DUNS: 204354752
• Company Name: Genomadix Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 18772287756
• Email: support@genomadix.com
• Phone: 18772287756
• Email: support@genomadix.com
• Phone: 18772287756
• Email: support@genomadix.com
• Phone: 18772287756
• Email: support@genomadix.com
• Phone: 18772287756
• Email: support@genomadix.com
• Phone: 18772287756
• Email: support@genomadix.com
• Phone: 18772287756
• Email: support@genomadix.com
• Phone: 18772287756
• Email: support@genomadix.com
• Phone: 18772287756
• Email: support@genomadix.com
• Phone: 18772287756
• Email: support@genomadix.com
• Phone: 18772287756
• Email: support@genomadix.com
• Phone: 18772287756
• Email: support@genomadix.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	G257ASM001160 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220026

FDA Product Code

• NTI: Drug Metabolizing Enzyme Genotyping Systems

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-06-24
• Device Publish Date: 2024-06-14

On-Brand Devices [Genomadix Cube CYP2C19]

• G257ASM001160: Each unit is a box of 5 training kits (containing water).
• G257ASM001030: Each unit is a box of 20 swabs.
• G257ASM001010: Genomadix Cube CYP2C19 System, Test Kit, Cartridges: Contains substances for DNA extraction, PCR
• G257ASM000990: Genomadix Cube CYP2C19 System, Control Kit, Cartridges. Box of 10 controls, reagents.
• G257ASM000960: This contains the laptop, cube, power adapter and cables.