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 Urine specimen collection kit IVD Urine specimen collection kit IVD Urine specimen collection kit IVD Urine specimen collection kit IVD Urine specimen collection kit IVD Urine specimen collection kit IVD Urine specimen collection kit IVD Urine specimen collection kit IVD Urine specimen collection kit IVD Urine specimen collection kit IVD Urine specimen collection kit IVD Urine specimen collection kit IVD Urine specimen collection kit IVD Urine specimen collection kit IVD Urine specimen collection kit IVD 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