INFINITI® CYP2C19 Amplification Mix 03-3220-01

GUDID 00850009370150

CYP2C19 drug metabolyzing enzyme genotyping system

AUTOGENOMICS, INC

Cytochrome P450 (CYP450) gene polymorphism IVD, kit, multiplex

• Primary Device ID: 00850009370150
• NIH Device Record Key: b6bbbb14-9d6e-459f-8d00-97fb9c3aa8f0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INFINITI® CYP2C19 Amplification Mix
• Version Model Number: 03-3220-01
• Catalog Number: 03-3220-01
• Company DUNS: 027914535
• Company Name: AUTOGENOMICS, INC
• Device Count: 1
• DM Exempt: true
• 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: +1(760)477-2248
• Email: techsupport@autogenomics.com
• Phone: +1(760)477-2248
• Email: techsupport@autogenomics.com
• Phone: +1(760)477-2248
• Email: techsupport@autogenomics.com
• Phone: +1(760)477-2248
• Email: techsupport@autogenomics.com
• Phone: +1(760)477-2248
• Email: techsupport@autogenomics.com
• Phone: +1(760)477-2248
• Email: techsupport@autogenomics.com
• Phone: +1(760)477-2248
• Email: techsupport@autogenomics.com
• Phone: +1(760)477-2248
• Email: techsupport@autogenomics.com
• Phone: +1(760)477-2248
• Email: techsupport@autogenomics.com
• Phone: +1(760)477-2248
• Email: techsupport@autogenomics.com
• Phone: +1(760)477-2248
• Email: techsupport@autogenomics.com
• Phone: +1(760)477-2248
• Email: techsupport@autogenomics.com
• Phone: +1(760)477-2248
• Email: techsupport@autogenomics.com
• Phone: +1(760)477-2248
• Email: techsupport@autogenomics.com
• Phone: +1(760)477-2248
• Email: techsupport@autogenomics.com
• Phone: +1(760)477-2248
• Email: techsupport@autogenomics.com
• Phone: +1(760)477-2248
• Email: techsupport@autogenomics.com
• Phone: +1(760)477-2248
• Email: techsupport@autogenomics.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -30 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -15 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850009370150 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101683

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: 2019-10-31
• Device Publish Date: 2019-10-23

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