QuantiFERON-TB Gold Blood Collection Tubes Dispens 5970405

GUDID 14053228002137

QIAGEN SCIENCES INC.

T-cell activation/stimulated interferon release IVD, reagent

• Primary Device ID: 14053228002137
• NIH Device Record Key: 951c7ef0-b591-45ac-a36d-bd3293a3bdb3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QuantiFERON-TB Gold Blood Collection Tubes Dispens
• Version Model Number: 1
• Catalog Number: 5970405
• Company DUNS: 008675485
• Company Name: QIAGEN SCIENCES INC.
• Device Count: 25
• 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	04053228002130 [Unit of Use]
GS1	14053228002137 [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

[14053228002137]

Radiation Sterilization

[14053228002137]

Radiation Sterilization

[14053228002137]

Radiation Sterilization

[14053228002137]

Radiation Sterilization

[14053228002137]

Radiation Sterilization

[14053228002137]

Radiation Sterilization

[14053228002137]

Radiation Sterilization

[14053228002137]

Radiation Sterilization

[14053228002137]

Radiation Sterilization

[14053228002137]

Radiation Sterilization

[14053228002137]

Radiation Sterilization

[14053228002137]

Radiation Sterilization

[14053228002137]

Radiation Sterilization

[14053228002137]

Radiation Sterilization

[14053228002137]

Radiation Sterilization

[14053228002137]

Radiation Sterilization

[14053228002137]

Radiation Sterilization

[14053228002137]

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

On-Brand Devices [QuantiFERON-TB Gold Blood Collection Tubes Dispens]

• 14053228002137: 1
• 14053228002120: QF-TB Gold Blood collection tubes - Dispenser Pack (25 single patient packs)