Leucosep Tubes LTK.615US

GUDID 05051716000087

Leucosep® tubes are intended for use in the collection and separation of peripheral blood mononuclear cells (PBMCs) from whole blood. The tubes facilitate the separation of PBMCs from whole blood when using a polysucrose-based gradient separation solution procedure prior to the use of these cells in ELISPOT assays. ELISPOT techniques utilize T cells in PBMCs that have been separated from whole blood. One method for separating these cells requires the use of a poly-sucrose-based gradient separation solution. This procedure involves a number of steps which should be carried out with care to ensure optimal results. The use of Leucosep tubes reduces the number of steps and reduces the amount of time required to perform the separation procedure.

Oxford Immunotec, Inc.

Cell centrifugation/density gradient separation reagent IVD

• Primary Device ID: 05051716000087
• NIH Device Record Key: 70be5dc4-b406-4c27-989f-5b8a3ee3cb18
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Leucosep Tubes
• Version Model Number: LTK.615
• Catalog Number: LTK.615US
• Company DUNS: 009744265
• Company Name: Oxford Immunotec, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05051716000087 [Primary]

FDA Product Code

• JCF: Lymphocyte Separation Medium

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: 2023-02-15
• Device Publish Date: 2023-02-07

On-Brand Devices [Leucosep Tubes]

• 05051716000087: Leucosep® tubes are intended for use in the collection and separation of peripheral blood monon
• 05051716000544: Leucosep® tubes are intended for use in the collection and separation of peripheral blood monon