GeneXpert Dx System 900-0140

GUDID 07332940003371

CEPHEID

Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated

• Primary Device ID: 07332940003371
• NIH Device Record Key: 4bff11a6-9f3b-43ac-8bc6-15d80de20e30
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GeneXpert Dx System
• Version Model Number: GXIV-2
• Catalog Number: 900-0140
• 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	07332940003371 [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: 3
• Public Version Date: 2019-10-25
• Device Publish Date: 2018-05-09

On-Brand Devices [GeneXpert Dx System]

• 07332940006815: Additional catalog number: 900-0425R
• 07332940006761: GXXVI-4
• 07332940006754: GXXVI-8
• 07332940006747: GXXVI-16
• 07332940006730: Additional catalog: 900-0391R
• 07332940006723: Additional catalog number: 900-0144R
• 07332940006716: GXIV-1
• 07332940006709: GXIV-3
• 07332940004361: Additional catalog number: 900-0523R
• 07332940004309: GXII-2
• 07332940004194: Additional catalog number: 900-0423R
• 07332940004170: Additional catalog number: 900-0424R
• 07332940004163: Additional catalog number: 900-0426R
• 07332940004156: Additional catalog number: 900-0427R
• 07332940004149: Additional catalog number: 900-0428R, 900-0428-10
• 07332940004132: Additional catalog number: 900-0429R, 900-0429-6
• 07332940004125: Additional catalog number: 900-0433R
• 07332940004071: Additional catalog: 900-0381R
• 07332940004057: Additional catalog: 900-0392R
• 07332940004040: Additional catalog: 900-0393R
• 07332940004033: Additional catalog numbers: 900-0400BT, 900-0400R
• 07332940003449: Additional catalog numbers: 900-0065R
• 07332940003388: GXIV-4
• 07332940003371: GXIV-2
• 07332940003364: Additional catalog: 900-0145R
• 07332940003357: Additional catalog: 900-0146R
• 07332940001483: Additional catalog numbers: 900-0521-14, 900-0521R
• 07332940001476: GXXVI-12
• 07332940001469: Additional catalog number: 900-0519R
• 07332940001452: Additional Catalog numbers: 900-0518-1, 900-0518-2, 900-0518-3, 900-0518-6
• 07332940001445: Additional catalog numbers: 900-0512-HE, 900-0512R
• 07332940001438: Additional catalog numbers: 900-0511-HE, 900-0511R
• 07332940001421: Additional catalog numbers: 900-0510-HE, 900-0510R
• 07332940001414: GXII-1
• 07332940001384: Other Brand Name: GeneXpert Xpress System; Other Version or Model Number: GXIV-CLIA-L Additional
• 07332940001377: Other Brand Name: GeneXpert Xpress System; Other Version or Model Number: GXII-CLIA-L
• 07332940001360: Additional catalog number: 900-0490R