Genomadix Cube CYP2C19,

GUDID ASM00101

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.

Genomadix Inc

Nucleic acid amplification mastermix kit IVD

• Primary Device ID: ASM00101
• NIH Device Record Key: 6f4a49ee-6051-43bb-9115-c0c67f7b1c63
• 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: true
• 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
• Phone: 18772287756
• Email: support@genomadix.com
• Phone: 18772287756
• Email: support@genomadix.com
• Phone: 18772287756
• Email: support@genomadix.com
• Phone: 18772287756
• Email: support@genomadix.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -80 Degrees Celsius and -15 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Shipping box contains dry ice.
• Storage Environment Temperature: Between -80 Degrees Celsius and -15 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Shipping box contains dry ice.
• Storage Environment Temperature: Between -80 Degrees Celsius and -15 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Shipping box contains dry ice.
• Storage Environment Temperature: Between -80 Degrees Celsius and -15 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Shipping box contains dry ice.
• Storage Environment Temperature: Between -80 Degrees Celsius and -15 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Shipping box contains dry ice.
• Storage Environment Temperature: Between -80 Degrees Celsius and -15 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Shipping box contains dry ice.
• Storage Environment Temperature: Between -80 Degrees Celsius and -15 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Shipping box contains dry ice.
• Storage Environment Temperature: Between -80 Degrees Celsius and -15 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Shipping box contains dry ice.
• Storage Environment Temperature: Between -80 Degrees Celsius and -15 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Shipping box contains dry ice.
• Storage Environment Temperature: Between -80 Degrees Celsius and -15 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Shipping box contains dry ice.
• Storage Environment Temperature: Between -80 Degrees Celsius and -15 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Shipping box contains dry ice.
• Storage Environment Temperature: Between -80 Degrees Celsius and -15 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Shipping box contains dry ice.
• Storage Environment Temperature: Between -80 Degrees Celsius and -15 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Shipping box contains dry ice.
• Storage Environment Temperature: Between -80 Degrees Celsius and -15 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Shipping box contains dry ice.
• Storage Environment Temperature: Between -80 Degrees Celsius and -15 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Shipping box contains dry ice.
• Storage Environment Temperature: Between -80 Degrees Celsius and -15 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Shipping box contains dry ice.

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	ASM00101 [Primary]

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: 2023-07-26
• Device Publish Date: 2023-07-18

Devices Manufactured by Genomadix Inc

• G257ASM000960 - Genomadix Cube CYP2C19: 2024-06-24 This contains the laptop, cube, power adapter and cables.
• G257ASM000990 - Genomadix Cube CYP2C19: 2024-06-24 Genomadix Cube CYP2C19 System, Control Kit, Cartridges. Box of 10 controls, reagents.
• G257ASM001010 - Genomadix Cube CYP2C19: 2024-06-24 Genomadix Cube CYP2C19 System, Test Kit, Cartridges: Contains substances for DNA extraction, PCR amplification, and detection of
• G257ASM001030 - Genomadix Cube CYP2C19: 2024-06-24 Each unit is a box of 20 swabs.
• G257ASM001160 - Genomadix Cube CYP2C19: 2024-06-24 Each unit is a box of 5 training kits (containing water).
• ASM00101 - Genomadix Cube CYP2C19,: 2023-07-26Genomadix 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.
• ASM00101 - Genomadix Cube CYP2C19,: 2023-07-26 Genomadix Cube CYP2C19 System, Test Kit, Cartridges: Contains substances for DNA extraction, PCR amplification, and detection of