GeneXpert® GXHCV-10

GUDID 07332940009366

Xpert® HCV

CEPHEID

Hepatitis C virus nucleic acid IVD, kit, nucleic acid technique (NAT)

• Primary Device ID: 07332940009366
• NIH Device Record Key: ec56e36d-5584-4744-9c2a-1832e7a8e74a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GeneXpert®
• Version Model Number: GXHCV-10
• Catalog Number: GXHCV-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: true
• Expiration Date: false
• 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
• 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
• 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
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07332940009366 [Primary]

FDA Product Code

• SBP: Simple Point-Of-Care Nucleic Acid-Based Hepatitis C Virus Ribonucleic Acid Test

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: 2024-07-30
• Device Publish Date: 2024-07-22

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