QuickVue TLI Lactoferrin Test

GUDID 00857031002585

The QuickVue TLI Lactoferrin Test is an immunochromatographic test for the qualitative detection of elevated levels of lactoferrin, a marker for fecal leukocytes and an indicator of intestinal inflammation. The test can be used as an in vitro diagnostic aid to help identify patients with active inflammatory bowel disease (IBD) and rule out those with active noninflammatory irritable bowel syndrome (IBS).

TECHLAB, INC.

Lactoferrin IVD, kit, immunochromatographic test (ICT)

• Primary Device ID: 00857031002585
• NIH Device Record Key: 57bee78c-c355-49cd-b2f7-474052cea350
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QuickVue TLI Lactoferrin Test
• Version Model Number: 20345
• Company DUNS: 614218634
• Company Name: TECHLAB, 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: true
• 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	00857031002585 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K030704

FDA Product Code

• DEG: Lactoferrin, Antigen, Antiserum, Control

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: 2019-06-07
• Device Publish Date: 2019-05-30

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