Genomadix Cube CYP2C19

GUDID G257ASM001030

Each unit is a box of 20 swabs.

Genomadix Inc

Oral/upper respiratory tract specimen collection swab IVD Oral/upper respiratory tract specimen collection swab IVD Oral/upper respiratory tract specimen collection swab IVD Oral/upper respiratory tract specimen collection swab IVD Oral/upper respiratory tract specimen collection swab IVD Oral/upper respiratory tract specimen collection swab IVD Oral/upper respiratory tract specimen collection swab IVD Oral/upper respiratory tract specimen collection swab IVD Oral/upper respiratory tract specimen collection swab IVD Oral/upper respiratory tract specimen collection swab IVD Oral/upper respiratory tract specimen collection swab IVD Oral/upper respiratory tract specimen collection swab IVD

• Primary Device ID: G257ASM001030
• NIH Device Record Key: 303ffe6e-b495-4811-b367-3c06ef40b3da
• 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: false
• 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	G257ASM001030 [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.