QuantiFERON®-TB Gold Plus 622529

GUDID 14053228033568

QFT-Plus Blood Collection Tubes (1200x)

QIAGEN SCIENCES INC.

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: 14053228033568
• NIH Device Record Key: ce12f14d-dab9-4071-9366-2247388b3dad
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QuantiFERON®-TB Gold Plus
• Version Model Number: 1
• Catalog Number: 622529
• Company DUNS: 008675485
• Company Name: QIAGEN SCIENCES 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	14053228033568 [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: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-12-26
• Device Publish Date: 2019-12-18

On-Brand Devices [QuantiFERON®-TB Gold Plus]

• 04053228015871: QFT-Plus Reference Lab Pack Elisa Kit
• 04053228015864: QFT-Plus 2 Plate Elisa Kit
• 14053228015915: QFT-Plus High Altitiude Blood Collection Tubes (25x)
• 14053228015908: QFT-Plus High Altitiude Blood Collection Tubes (50x)
• 14053228015892: QFT-Plus Blood Collection Tubes (50x)
• 14053228015885: QFT-Plus Blood Collection Tubes (25x)
• 14053228033575: QFT-Plus High Altitude Blood Collection Tubes (1200x)
• 14053228033568: QFT-Plus Blood Collection Tubes (1200x)