QuantiFERON-TB Gold Reference Lab Pack 5940501

GUDID 04053228002116

QIAGEN SCIENCES INC.

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

• Primary Device ID: 04053228002116
• NIH Device Record Key: 7cafb5bc-d85a-4b5c-a14a-493ae2676eea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QuantiFERON-TB Gold Reference Lab Pack
• Version Model Number: 1
• Catalog Number: 5940501
• 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	04053228002116 [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: 2017-01-04

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