QuantiFERON-TB Gold Blood Collection Tubes - High T05900505

GUDID 14053228002151

bulk pack

QIAGEN SCIENCES INC.

T-cell activation/stimulated interferon release IVD, reagent T-cell activation/stimulated interferon release IVD, reagent Interferon gamma release IVD, reagent Interferon gamma release IVD, reagent Interferon gamma release IVD, reagent Interferon gamma release IVD, reagent Interferon gamma release IVD, reagent Interferon gamma release IVD, reagent Interferon gamma release IVD, reagent Interferon gamma release IVD, reagent Interferon gamma release IVD, reagent Interferon gamma release IVD, reagent Interferon gamma release IVD, reagent Interferon gamma release IVD, reagent Interferon gamma release IVD, reagent Interferon gamma release IVD, reagent Interferon gamma release IVD, reagent Interferon gamma release IVD, reagent

• Primary Device ID: 14053228002151
• NIH Device Record Key: ec1205bb-ea71-47c2-9878-c219d703f8e2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QuantiFERON-TB Gold Blood Collection Tubes - High
• Version Model Number: 1
• Catalog Number: T05900505
• Company DUNS: 008675485
• Company Name: QIAGEN SCIENCES INC.
• Device Count: 100
• DM Exempt: false
• 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: 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04053228002154 [Unit of Use]
GS1	14053228002151 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P010033

FDA Product Code

• NCD: Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis

Sterilization

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

[14053228002151]

Radiation Sterilization

[14053228002151]

Radiation Sterilization

[14053228002151]

Radiation Sterilization

[14053228002151]

Radiation Sterilization

[14053228002151]

Radiation Sterilization

[14053228002151]

Radiation Sterilization

[14053228002151]

Radiation Sterilization

[14053228002151]

Radiation Sterilization

[14053228002151]

Radiation Sterilization

[14053228002151]

Radiation Sterilization

[14053228002151]

Radiation Sterilization

[14053228002151]

Radiation Sterilization

[14053228002151]

Radiation Sterilization

[14053228002151]

Radiation Sterilization

[14053228002151]

Radiation Sterilization

[14053228002151]

Radiation Sterilization

[14053228002151]

Radiation Sterilization

[14053228002151]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-01-04

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• 14053228002151 - QuantiFERON-TB Gold Blood Collection Tubes - High: 2018-07-06bulk pack
• 14053228002151 - QuantiFERON-TB Gold Blood Collection Tubes - High: 2018-07-06 bulk pack