GeneXpert® GX-II R2

GUDID 07332940007683

XPERT, GENEXPERT DX SYSTEM

CEPHEID

Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated

• Primary Device ID: 07332940007683
• NIH Device Record Key: abbeb867-b22d-4b25-b87a-b0cd09d6bff0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GeneXpert®
• Version Model Number: GX-II R2
• Catalog Number: GX-II R2
• 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: false
• 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: 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
• 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
• 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	07332940007683 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060540

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: 2022-05-11
• Device Publish Date: 2022-05-03

On-Brand Devices [GeneXpert®]

• 07332940007720: Xpert MTB/RIF Assay, GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, GeneXpert Infi
• 07332940007713: Xpert MTB/RIF Assay, GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, GeneXpert Infi
• 07332940007706: XPERT, GENEXPERT DX SYSTEM
• 07332940007690: XPERT, GENEXPERT DX SYSTEM
• 07332940007683: XPERT, GENEXPERT DX SYSTEM
• 07332940007195: Xpress System
• 07332940008604: Xpert Xpress CoV-2/Flu/RSV plus
• 07332940008581: Xpert® Xpress CoV-2 plus
• 07332940008161: Xpert® Xpress GBS
• 07332940009366: Xpert® HCV