Xpert FLU/RSV XC GXFLU/RSV-10

GUDID 07332940000783

Xpert FLU/RSV XC kit; 10 test kit

CEPHEID

Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)

• Primary Device ID: 07332940000783
• NIH Device Record Key: 03e6b4f0-26d8-4293-b21e-daab64dcd559
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Xpert FLU/RSV XC
• Version Model Number: GXFLU/RSV-10
• Catalog Number: GXFLU/RSV-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: 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
• 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
• 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
• 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
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07332940000783 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142045

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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