Xpert Flu+RSV Xpress

Basic Information

• Brand Name: Xpert Flu+RSV Xpress
• Primary DI: 07332940005177
• Version / Model: GXFLU+RSV-XP-10
• Catalog Number: GXFLU+RSV-XP-10
• Company Name: CEPHEID
• Labeler DUNS: 956711444
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-01-29
• Public Version: 7
• Public Version Date: 2023-12-18
• Public Version Status: Update
• Public Device Record Key: 12ab9505-c2ae-4c0b-8157-7d2a54b5f585
• Distribution End Date: 2022-05-12

Device Description

Xpert Flu+RSV Xpress kit; 10 test kit

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OCC	Respiratory Virus Panel Nucleic Acid Assay System	Microbiology	866.3980	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47922	Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from multiple virus genera associated with respiratory diseases in a clinical specimen, using a nucleic acid technique (NAT). Viruses intended to be detected may include respiratory syncytial virus (RSV), influenza viruses, parainfluenza viruses, human metapneumovirus, coronaviruses, enteroviruses, rhinoviruses and/or adenoviruses. This test is commonly used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07332940005177	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K151226	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 28 Degrees Celsius