GeneXpert® Xpress GX-IV Xpress

GUDID 07332940009243

GENEXPERT Xpress System

CEPHEID

Thermal cycler nucleic acid amplification analyser IVD, laboratory

• Primary Device ID: 07332940009243
• NIH Device Record Key: 8f9a9840-9082-435a-93dd-34e7ec25ff27
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GeneXpert® Xpress
• Version Model Number: GX-IV Xpress
• Catalog Number: GX-IV Xpress
• 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

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
• 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 -30 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 45 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07332940009243 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171552

FDA Product Code

• OOI: Real Time Nucleic Acid Amplification 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: 2023-10-30
• Device Publish Date: 2023-10-20

Devices Manufactured by CEPHEID

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• 07332940008161 - GeneXpert®: 2024-02-26 Xpert® Xpress GBS
• 07332940008581 - GeneXpert®: 2024-01-30 Xpert® Xpress CoV-2 plus
• 07332940009243 - GeneXpert® Xpress: 2023-10-30GENEXPERT Xpress System
• 07332940009243 - GeneXpert® Xpress: 2023-10-30 GENEXPERT Xpress System
• 07332940008604 - GeneXpert®: 2023-10-03 Xpert Xpress CoV-2/Flu/RSV plus
• 07332940007652 - Xpert®: 2022-08-08 GBS LB XC
• 07332940007669 - Xpert®: 2022-08-08 GBS LB XC
• 07332940007195 - GeneXpert®: 2022-05-20 Xpress System