LACTOFERRIN SCAN

GUDID 00857031002097

The LACTOFERRIN SCAN® test is a quantitative ELISA for measuring concentrations of fecal lactoferrin, a marker for fecal leukocytes. An elevated level is an indicator of intestinal inflammation. The test can be used as an in vitro diagnostic aid to distinguish patients with active inflammatory bowel disease (IBD) from those with noninflammatory irritable bowel syndrome (IBS).

TECHLAB, INC.

Lactoferrin IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 00857031002097
• NIH Device Record Key: 1c2b3cbb-5cf6-4922-a516-943b262b046c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LACTOFERRIN SCAN
• Version Model Number: 30351
• 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	00857031002097 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042071

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 [LACTOFERRIN SCAN]

• 00857031002288: The LACTOFERRIN SCAN® test is a quantitative ELISA for measuring concentrations of fecal lactof
• 00857031002097: The LACTOFERRIN SCAN® test is a quantitative ELISA for measuring concentrations of fecal lactof