xTAG® Cystic Fibrosis Mutation Detection Kit I006C0068

GUDID 00840487100455

The xTAG® Cystic Fibrosis Kit is a device used to simultaneously detect and identify a panel of mutations and variants in the cystic fibrosis transmembrane conductance regulator (CFTR) gene in human blood specimens

Luminex Molecular Diagnostics, Inc

Cystic fibrosis IVD, kit, multiplex

• Primary Device ID: 00840487100455
• NIH Device Record Key: 5b25ecf7-4ee2-4a75-9151-29cd80aad865
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: xTAG® Cystic Fibrosis Mutation Detection Kit
• Version Model Number: I006C0068
• Catalog Number: I006C0068
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840487100455 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060627

FDA Product Code

• NUA: System, cystic fibrosis transmembrane conductance regulator, gene mutation detection

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

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