T.Cell Xtend® TTK.610US

GUDID 15051716000022

Approval for the use of t-cell xtend reagent with the t-spot. Tb test, in order to extend the time from sample collection to sample processing from wi

Oxford Immunotec, Inc.

Cell centrifugation/density gradient separation reagent IVD Cell centrifugation/density gradient separation reagent IVD

• Primary Device ID: 15051716000022
• NIH Device Record Key: 60c1d520-5387-412e-bb88-35aea82359e0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: T.Cell Xtend®
• Version Model Number: TTK.610
• Catalog Number: TTK.610US
• Company DUNS: 009744265
• Company Name: Oxford Immunotec, 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: 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: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	15051716000022 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P070006

FDA Product Code

• OJN: Mycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-Linked Immunospot Test

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2014-08-12

On-Brand Devices [T.Cell Xtend®]

• 15051716000053: Approval for the use of t-cell xtend reagent with the t-spot. Tb test, in order to extend the ti
• 15051716000022: Approval for the use of t-cell xtend reagent with the t-spot. Tb test, in order to extend the ti