Xpert Flu GXFLU-10A

GUDID 07332940001070

Xpert Flu kit; 10 test kit

CEPHEID

Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT) Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT) Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT) Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT) Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT) Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT) Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT) Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT) Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT) Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT) Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT) Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT) Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT) Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

• Primary Device ID: 07332940001070
• NIH Device Record Key: cfca8b9e-a8b7-4eca-b467-f9f4b2f5dccf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Xpert Flu
• Version Model Number: GXFLU-10A
• Catalog Number: GXFLU-10A
• 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: false
• Expiration Date: true
• 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: 1 888 838 3222
• Email: techsupport@cepheid.com
• Phone: 1 888 838 3222
• Email: techsupport@cepheid.com
• Phone: 1 888 838 3222
• Email: techsupport@cepheid.com
• Phone: 1 888 838 3222
• Email: techsupport@cepheid.com
• Phone: 1 888 838 3222
• Email: techsupport@cepheid.com
• Phone: 1 888 838 3222
• Email: techsupport@cepheid.com
• Phone: 1 888 838 3222
• Email: techsupport@cepheid.com
• Phone: 1 888 838 3222
• Email: techsupport@cepheid.com
• Phone: 1 888 838 3222
• Email: techsupport@cepheid.com
• Phone: 1 888 838 3222
• Email: techsupport@cepheid.com
• Phone: 1 888 838 3222
• Email: techsupport@cepheid.com
• Phone: 1 888 838 3222
• Email: techsupport@cepheid.com
• Phone: 1 888 838 3222
• Email: techsupport@cepheid.com
• Phone: 1 888 838 3222
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07332940001070 [Primary]

FDA Product Code

• OQW: 2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2018-01-29

Devices Manufactured by CEPHEID

• 07332940008161 - GeneXpert®: 2024-02-26 Xpert® Xpress GBS
• 07332940008581 - GeneXpert®: 2024-01-30 Xpert® Xpress CoV-2 plus
• 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
• 07332940006457 - Xpert®: 2022-05-11 Nasal Sample Collect Kit for Viruses