Respiratory Pathogens Flex (RP Flex) Nucleic Acid Test Cartridge

Basic Information

• Brand Name: Respiratory Pathogens Flex (RP Flex) Nucleic Acid Test Cartridge
• Primary DI: 00857573006164
• Version / Model: 20-006-024
• Company Name: NANOSPHERE, INC.
• Labeler DUNS: 164757242
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 7
• Public Version Date: 2023-12-18
• Public Version Status: Update
• Public Device Record Key: 65a83378-f578-4a08-808b-488f51bf745c
• Distribution End Date: 2019-12-05

Device Description

The Verigene® Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) is a multiplexed qualitative test intended for the simultaneous detection and identification of multiple viral and bacterial nucleic acids in nasopharyngeal swabs (NPS) obtained from individuals suspected of respiratory tract infection.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• 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
OZE	Influenza A And Influenza B Multiplex Nucleic Acid Assay	Microbiology	866.3980	2
OEM	Human Metapneumovirus (Hmpv) Rna Assay System	Microbiology	866.3980	2
OCC	Respiratory Virus Panel Nucleic Acid Assay System	Microbiology	866.3980	2
OEP	Influenza A Virus Subtype Differentiation Nucleic Acid Assay	Microbiology	866.3980	2
OZZ	Bordetella Pertussis Dna Assay System	Microbiology	866.3980	2
OOU	Parainfluenza Multiplex Nucleic Acid Assay	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	00857573006164	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K143653	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius