T-SPOT®.TB8 TB.300US

GUDID 15051716000305

For the detection of effector t cells that respond to stimulation by mycobacterium tuberculosis antigens esat-6 and cfp-10 and indicated for use as an

Oxford Immunotec, Inc.

Mycobacterium tuberculosis complex species antigen IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 15051716000305
• NIH Device Record Key: 19e99fa4-a37a-4a9b-afa6-72d912e3d30b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: T-SPOT®.TB8
• Version Model Number: TB.300
• Catalog Number: TB.300US
• 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: 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: 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	15051716000305 [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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2014-08-12

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