T-Cell Select® TSK.910US

GUDID 05051716000186

The T-SPOT.TB test has been evaluated for the processing of blood samples within 8 hours of venipuncture. With the T-Cell Select reagent kit, blood samples stored or maintained at room temperature (18 – 25 °C) for up to 54 (0 – 54) hours post venipuncture can be used with the T-SPOT.TB test. The T-Cell Select reagent may also enable automation of the cell isolation process and reduce sample separation time relative to preparation via the density gradient separation methodology. With the T-Cell Select reagent kit, blood samples may be shipped and/or stored overnight at room temperature (18 – 25 °C), up to 54 (0 – 54) hours post venipuncture.

Oxford Immunotec, Inc.

T lymphocyte magnetic separation reagent IVD T lymphocyte magnetic separation reagent IVD T lymphocyte magnetic separation reagent IVD T lymphocyte magnetic separation reagent IVD T lymphocyte magnetic separation reagent IVD T lymphocyte magnetic separation reagent IVD T lymphocyte magnetic separation reagent IVD T lymphocyte magnetic separation reagent IVD T lymphocyte magnetic separation reagent IVD T lymphocyte magnetic separation reagent IVD T lymphocyte magnetic separation reagent IVD T lymphocyte magnetic separation reagent IVD T lymphocyte magnetic separation reagent IVD T lymphocyte magnetic separation reagent IVD T lymphocyte magnetic separation reagent IVD T lymphocyte magnetic separation reagent IVD T lymphocyte magnetic separation reagent IVD

• Primary Device ID: 05051716000186
• NIH Device Record Key: fecc2d1c-c4bc-4942-af2e-da8de5ae5be7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: T-Cell Select®
• Version Model Number: TSK.910
• Catalog Number: TSK.910US
• Company DUNS: 009744265
• Company Name: Oxford Immunotec, 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: 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	05051716000186 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-02-15
• Device Publish Date: 2023-02-07

Devices Manufactured by Oxford Immunotec, Inc.

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• 05051716000087 - Leucosep Tubes: 2023-02-15 Leucosep® tubes are intended for use in the collection and separation of peripheral blood mononuclear cells (PBMCs) from whole
• 05051716000155 - AIM-V Medium: 2023-02-15 AIM-V® serum free cell culture medium is intended for use in the preparation of peripheral blood mononuclear cells (PBMCs) from
• 05051716000162 - AIM-V Medium: 2023-02-15 AIM-V® serum free cell culture medium is intended for use in the preparation of peripheral blood mononuclear cells (PBMCs) from
• 05051716000186 - T-Cell Select®: 2023-02-15The T-SPOT.TB test has been evaluated for the processing of blood samples within 8 hours of venipuncture. With the T-Cell Select reagent kit, blood samples stored or maintained at room temperature (18 – 25 °C) for up to 54 (0 – 54) hours post venipuncture can be used with the T-SPOT.TB test. The T-Cell Select reagent may also enable automation of the cell isolation process and reduce sample separation time relative to preparation via the density gradient separation methodology. With the T-Cell Select reagent kit, blood samples may be shipped and/or stored overnight at room temperature (18 – 25 °C), up to 54 (0 – 54) hours post venipuncture.
• 05051716000186 - T-Cell Select®: 2023-02-15 The T-SPOT.TB test has been evaluated for the processing of blood samples within 8 hours of venipuncture. With the T-Cell Select
• 15051716000008 - T-SPOT®.TB96: 2018-07-06 For the detection of effector t cells that respond to stimulation by mycobacterium tuberculosis antigens esat-6 and cfp-10 and i
• 15051716000022 - T.Cell Xtend®: 2018-07-06 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 sam
• 15051716000046 - T-SPOT®.TB50: 2018-07-06 For the detection of effector t cells that respond to stimulation by mycobacterium tuberculosis antigens esat-6 and cfp-10 and i