LEUKO EZ VUE

GUDID 00857031002530

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) Lactoferrin IVD, kit, rapid ICT, clinical Lactoferrin IVD, kit, rapid ICT, clinical Lactoferrin IVD, kit, rapid ICT, clinical Lactoferrin IVD, kit, rapid ICT, clinical Lactoferrin IVD, kit, rapid ICT, clinical Lactoferrin IVD, kit, rapid ICT, clinical Lactoferrin IVD, kit, rapid ICT, clinical Lactoferrin IVD, kit, rapid ICT, clinical Lactoferrin IVD, kit, rapid ICT, clinical Lactoferrin IVD, kit, rapid ICT, clinical Lactoferrin IVD, kit, rapid ICT, clinical Lactoferrin IVD, kit, rapid ICT, clinical Lactoferrin IVD, kit, rapid ICT, clinical Lactoferrin IVD, kit, rapid ICT, clinical Lactoferrin IVD, kit, rapid ICT, clinical Lactoferrin IVD, kit, rapid ICT, clinical Lactoferrin IVD, kit, rapid ICT, clinical Lactoferrin IVD, kit, rapid ICT, clinical Lactoferrin IVD, kit, rapid ICT, clinical Lactoferrin IVD, kit, rapid ICT, clinical Lactoferrin IVD, kit, rapid ICT, clinical Lactoferrin IVD, kit, rapid ICT, clinical Lactoferrin IVD, kit, rapid ICT, clinical Lactoferrin IVD, kit, rapid ICT, clinical

• Primary Device ID: 00857031002530
• NIH Device Record Key: fbb6b05d-fa8e-4b98-870f-321c26d09cb1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LEUKO EZ VUE
• Version Model Number: T5019
• 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	00857031002530 [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: 2020-02-03
• Device Publish Date: 2020-01-24

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