Xpert GXGI-10

GUDID 07332940009489

Xpert GI Panel

CEPHEID

Multiple-genus gastrointestinal disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT)

• Primary Device ID: 07332940009489
• NIH Device Record Key: de1b2f28-1124-4044-89d3-0d9a2d1d03f0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Xpert
• Version Model Number: GXGI-10
• Catalog Number: GXGI-10
• Company DUNS: 956711444
• Company Name: CEPHEID
• 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

Customer Support Contacts

• Phone: 18888383222
• Email: techsupport@cepheid.com
• Phone: 18888383222
• Email: techsupport@cepheid.com
• Phone: 18888383222
• Email: techsupport@cepheid.com
• Phone: 18888383222
• Email: techsupport@cepheid.com
• Phone: 18888383222
• Email: techsupport@cepheid.com
• Phone: 18888383222
• Email: techsupport@cepheid.com
• Phone: 18888383222
• Email: techsupport@cepheid.com
• Phone: 18888383222
• Email: techsupport@cepheid.com
• Phone: 18888383222
• Email: techsupport@cepheid.com
• Phone: 18888383222
• Email: techsupport@cepheid.com
• Phone: 18888383222
• Email: techsupport@cepheid.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07332940009489 [Primary]

FDA Product Code

• PCH: Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System

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: 2026-02-09
• Device Publish Date: 2026-01-30

Devices Manufactured by CEPHEID

• 07332940009489 - Xpert: 2026-02-09Xpert GI Panel
• 07332940009489 - Xpert: 2026-02-09 Xpert GI Panel
• 07332940009694 - GeneXpert®: 2026-01-27 GENEXPERT DX SYSTEM Refurbished
• 07332940009700 - GeneXpert® Xpress: 2026-01-27 GENEXPERT Xpress System Refurbished
• 07332940009687 - GeneXpert®: 2025-08-25 GENEXPERT DX SYSTEM Refurb
• 07332940009366 - GeneXpert®: 2024-07-30 Xpert® HCV
• 07332940008161 - GeneXpert®: 2024-02-26 Xpert® Xpress GBS
• 07332940008581 - GeneXpert®: 2024-01-30 Xpert® Xpress CoV-2 plus
• 07332940009243 - GeneXpert® Xpress: 2023-10-30 GENEXPERT Xpress System