Xpert Xpress Flu XPRSFLU-10

GUDID 07332940006044

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

• Primary Device ID: 07332940006044
• NIH Device Record Key: 9088065c-dcbd-4002-a9a7-d0f9a7277586
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Xpert Xpress Flu
• Version Model Number: XPRSFLU-10
• Catalog Number: XPRSFLU-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: true
• 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
• Phone: 1 888 838 3222
• Email: techsupport@cepheid.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07332940006044 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162456

FDA Product Code

• OCC: Respiratory Virus Panel Nucleic Acid Assay 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: 2018-07-06
• Device Publish Date: 2018-01-29

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