Verigene Respiratory Virus Nucleic Acid Test on the Verigene SP System (RVNATSP)

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K092566 ↗

FDA Product Code

OCC

Device Class

Class II

Regulation

21 CFR Part 866.3980

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

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• Verigene CYP2C19 Nucleic Acid Tes (2C19)

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See all devices from Nanosphere, Inc. →

• What viruses does the Verigene RVNATSP test for?

  The Verigene Respiratory Virus Nucleic Acid Test on the Verigene SP System (RVNATSP) is designed to detect and identify nucleic acids from three specific respiratory viruses: Influenza A Virus, Influenza B Virus, and Respiratory Syncytial Virus (RSV). It uses a multiplex assay to simultaneously test for all three viruses in a single nasopharyngeal swab specimen, making it efficient for diagnosing common respiratory infections in symptomatic patients.

• Is the Verigene RVNATSP a single-use or reusable device?

  The Verigene RVNATSP is supplied as a single-use diagnostic device. This design ensures patient safety and sterility, as each test is intended for one-time use only. Reusing the device could compromise accuracy and introduce contamination risks, so adherence to single-use guidelines is critical.

• What type of specimen is required for the Verigene RVNATSP?

  The Verigene RVNATSP is intended for use with nasopharyngeal swab specimens collected from symptomatic patients. Nasopharyngeal swabs are commonly used for respiratory virus testing due to their ability to capture viral nucleic acids effectively from the upper respiratory tract, where these viruses often reside.

• How is the Verigene RVNATSP regulated and approved?

  The Verigene RVNATSP has received FDA clearance through a 510(k) submission, which means it has been determined to be substantially equivalent to a legally marketed device. It is classified as a Class II medical device under the regulatory code 866.3980, indicating it poses moderate risk and requires specific controls to ensure safety and effectiveness. The device is not intended for MRI use.

• What storage and handling guidelines should be followed for the Verigene RVNATSP?

  The Verigene RVNATSP must be stored and handled according to the manufacturer’s guidelines to maintain its performance and integrity. While specific storage conditions are not detailed in the provided data, typical nucleic acid tests require protection from extreme temperatures, light exposure, and contamination. Always refer to the manufacturer’s instructions for precise storage recommendations, such as refrigeration or room temperature storage, and ensure proper labeling and expiration checks before use.