Verigene Respiratory Virus Nucleic Acid Test on the Verigene SP System

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

510(k) Number

K093337 ↗

FDA Product Code

OCC

Device Class

Class II

Regulation

21 CFR Part 866.3980

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

• Verigene Gram Negative Blood Culture Nucleic Acid Test (Bc-Gn) Open recall

  Class II

  FDA 510(k) K132843 Active Cleared 8 Jan 2014

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

  Class II

  FDA 510(k) K092566 Active Cleared 9 Oct 2009

• Verigene System, Verigene Warfarin Metabolism Nucleic Acid Test

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  FDA 510(k) K070804 Active Cleared 17 Sep 2007

• Verigene C. Difficile Nucleic Acid Test (Cdf) Open recall

  Class II

  FDA 510(k) K123197 Active Cleared 5 Dec 2012

• Verigene Respiratory Virus Nucleic Acid Test +(Rvnat+)

  Class II

  FDA 510(k) K103209 Active Cleared 10 Jan 2011

• Verigene Enteric Pathogen Nucleic Acid Test (EP) Open recall

  Class II

  FDA 510(k) K140083 Active Cleared 20 Jun 2014

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• What viruses does the Verigene Respiratory Virus Test detect?

  The Verigene Respiratory Virus Test is designed to detect and identify nucleic acids from Influenza A, Influenza B, and Respiratory Syncytial Virus (RSV) in nasopharyngeal swab specimens. It does not detect Influenza C virus, so results should not be used as the sole basis for excluding infection from this virus.

• How is the Verigene Respiratory Virus Test supplied and used?

  The Verigene Respiratory Virus Test is supplied as a single-use, in vitro diagnostic device intended for use on the Verigene SP System. It is processed in a clinical laboratory setting, where it provides rapid, multiplex nucleic acid detection for clinical decision-making. The test requires laboratory infrastructure and trained personnel to operate the Verigene SP System.

• Is sterility and proper storage important for this test?

  Yes, sterility and proper storage conditions are critical for maintaining the integrity of the Verigene Respiratory Virus Test. The device must be stored under conditions that preserve its functionality, as contamination or improper handling could compromise the accuracy of the results. Always follow the manufacturer’s guidelines for storage and handling.

• Can the Verigene Respiratory Virus Test be reused?

  No, the Verigene Respiratory Virus Test is designed as a single-use device. Each test kit is intended for one-time use only, ensuring accuracy and preventing cross-contamination between specimens. Discard any unused portions after testing.

• What regulatory approval does the Verigene Respiratory Virus Test hold?

  The Verigene Respiratory Virus Test holds FDA 510(k) clearance (K093337) under the Microbiology advisory committee, classified as a Class 2 device regulated under FDA regulation 866.3980. This clearance indicates that the device has been deemed substantially equivalent to a legally marketed predicate device.