QuantiFERON®-TB Gold Plus 622832

GUDID 04053228015871

QFT-Plus Reference Lab Pack Elisa Kit

QIAGEN SCIENCES INC.

T-cell activation/stimulated interferon release IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 04053228015871
• NIH Device Record Key: b386ac0c-4130-4e82-8270-a7055aad010e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QuantiFERON®-TB Gold Plus
• Version Model Number: 1
• Catalog Number: 622832
• 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: 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04053228015871 [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-10-02

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)