Genova Diagnostics

GUDID 00860010591109

The Intestinal Permeability Drink Concentrate is intended to facilitate the measurement of lactulose to mannitol in urine; the measurement is used in the diagnosis of gastrointestinal malabsorption syndroms

Genova Diagnostics, Inc.

Urine specimen collection kit IVD

• Primary Device ID: 00860010591109
• NIH Device Record Key: 65a61a6b-83c3-47e2-baae-dfd43f04c7a7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Genova Diagnostics
• Version Model Number: Intestinal Permeability Drink Concentrate
• Company DUNS: 603179581
• Company Name: Genova Diagnostics, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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

Customer Support Contacts

• Phone: 800-522-4762
• Email: xxx@xx.xx
• Phone: 800-522-4762
• Email: xxx@xx.xx
• Phone: 800-522-4762
• Email: xxx@xx.xx
• Phone: 800-522-4762
• Email: xxx@xx.xx
• Phone: 800-522-4762
• Email: xxx@xx.xx
• Phone: 800-522-4762
• Email: xxx@xx.xx
• Phone: 800-522-4762
• Email: xxx@xx.xx
• Phone: 800-522-4762
• Email: xxx@xx.xx
• Phone: 800-522-4762
• Email: xxx@xx.xx
• Phone: 800-522-4762
• Email: xxx@xx.xx
• Phone: 800-522-4762
• Email: xxx@xx.xx
• Phone: 800-522-4762
• Email: xxx@xx.xx
• Phone: 800-522-4762
• Email: xxx@xx.xx
• Phone: 800-522-4762
• Email: xxx@xx.xx
• Phone: 800-522-4762
• Email: xxx@xx.xx
• Phone: 800-522-4762
• Email: xxx@xx.xx
• Phone: 800-522-4762
• Email: xxx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860010591109 [Primary]

FDA Product Code

• JOC: Colorimetric, Xylose

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: 2023-08-16
• Device Publish Date: 2023-08-08