xTAG® CYP2D6 Kit v3 I030B0373

GUDID 00840487100134

The xTAG® CYP2D6 Kit v3 is a device used to simultaneously detect and identify a panel of nucleotide variants found within the highly polymorphic CYP2D6 gene located on chromosome 22 from genomic DNA extracted from EDTA and citrate anticoagulated whole blood samples.

Luminex Molecular Diagnostics, Inc

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

• Primary Device ID: 00840487100134
• NIH Device Record Key: 008729b7-8ea6-46c2-9501-c75db4c00012
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: xTAG® CYP2D6 Kit v3
• Version Model Number: I030B0373
• Catalog Number: I030B0373
• Company DUNS: 255371916
• Company Name: Luminex Molecular Diagnostics, 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: false
• 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(877)785-2323
• Email: support@luminexcorp.com
• Phone: +1(877)785-2323
• Email: support@luminexcorp.com
• Phone: +1(877)785-2323
• Email: support@luminexcorp.com
• Phone: +1(877)785-2323
• Email: support@luminexcorp.com
• Phone: +1(877)785-2323
• Email: support@luminexcorp.com
• Phone: +1(877)785-2323
• Email: support@luminexcorp.com
• Phone: +1(877)785-2323
• Email: support@luminexcorp.com
• Phone: +1(877)785-2323
• Email: support@luminexcorp.com
• Phone: +1(877)785-2323
• Email: support@luminexcorp.com
• Phone: +1(877)785-2323
• Email: support@luminexcorp.com
• Phone: +1(877)785-2323
• Email: support@luminexcorp.com
• Phone: +1(877)785-2323
• Email: support@luminexcorp.com
• Phone: +1(877)785-2323
• Email: support@luminexcorp.com
• Phone: +1(877)785-2323
• Email: support@luminexcorp.com
• Phone: +1(877)785-2323
• Email: support@luminexcorp.com
• Phone: +1(877)785-2323
• Email: support@luminexcorp.com
• Phone: +1(877)785-2323
• Email: support@luminexcorp.com
• Phone: +1(877)785-2323
• Email: support@luminexcorp.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 6 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 6 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 6 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 6 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 6 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 6 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 6 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 6 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 6 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 6 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 6 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 6 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 6 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 6 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 6 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 6 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 6 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840487100134 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093420

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-09

On-Brand Devices [xTAG® CYP2D6 Kit v3]

• 00840487101025: The xTAG® CYP2D6 Kit v3 is a device used to simultaneously detect and identify a panel of nucle
• 00840487100134: The xTAG® CYP2D6 Kit v3 is a device used to simultaneously detect and identify a panel of nucle