LEUKO EZ VUE

GUDID 00857031002172

The LEUKO EZ VUE® test is an immunochromatographic test for the qualitative detection of elevated levels of fecal lactoferrin, a marker for fecal leukocytes and an indicator of intestinal inflammation. The LEUKO EZ VUE® test detects lactoferrin in liquid, semi-solid, and solid fecal specimens. A positive test result indicates an increased level of fecal lactoferrin and warrants additional testing.

TECHLAB, INC.

Lactoferrin IVD, kit, immunochromatographic test (ICT)

• Primary Device ID: 00857031002172
• NIH Device Record Key: e93109c8-ec96-42cd-adfe-8e4ef92eaf94
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LEUKO EZ VUE
• Version Model Number: T30355
• 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: 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	00857031002172 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K071712

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: 2019-04-22
• Device Publish Date: 2019-04-12

On-Brand Devices [LEUKO EZ VUE]

• 00857031002172: The LEUKO EZ VUE® test is an immunochromatographic test for the qualitative detection of elevat
• 00857031002530: The LEUKO EZ VUE® test is an immunochromatographic test for the qualitative detection of elevat