Certified Pre-Owned GeneXpert Dx System 900-0520R

GUDID 07332940004385

CEPHEID

Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated Thermal cycler nucleic acid amplification analyser IVD, laboratory Thermal cycler nucleic acid amplification analyser IVD, laboratory Thermal cycler nucleic acid amplification analyser IVD, laboratory Thermal cycler nucleic acid amplification analyser IVD, laboratory Thermal cycler nucleic acid amplification analyser IVD, laboratory Thermal cycler nucleic acid amplification analyser IVD, laboratory Thermal cycler nucleic acid amplification analyser IVD, laboratory Thermal cycler nucleic acid amplification analyser IVD, laboratory Thermal cycler nucleic acid amplification analyser IVD, laboratory Thermal cycler nucleic acid amplification analyser IVD, laboratory Thermal cycler nucleic acid amplification analyser IVD, laboratory Thermal cycler nucleic acid amplification analyser IVD, laboratory Thermal cycler nucleic acid amplification analyser IVD, laboratory Thermal cycler nucleic acid amplification analyser IVD, laboratory

• Primary Device ID: 07332940004385
• NIH Device Record Key: f6b23a9f-cd68-4bff-84ca-a291d3b5c352
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Certified Pre-Owned GeneXpert Dx System
• Version Model Number: GXXVI-12-R
• Catalog Number: 900-0520R
• 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
• 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
• 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	07332940004385 [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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-10-25
• Device Publish Date: 2016-09-12

On-Brand Devices [Certified Pre-Owned GeneXpert Dx System]

• 07332940004408: GXXVI-4-R
• 07332940004392: GXXVI-8-R
• 07332940004385: GXXVI-12-R
• 07332940004378: GXXVI-16-R
• 07332940003951: GXII-1-R
• 07332940003937: GXIV-1-R
• 07332940003920: GXIV-2-R
• 07332940003913: GXIV-3-R
• 07332940003890: GXIV-4-R
• 07332940003852: GXII-2-R