Verigene Respiratory Virus Nucleic Acid Test +(Rvnat+)

• • Terminated Z-2684-2014 FDA Class II ·initiated 10 Oct 2013

  Nanosphere has received several reports relating to an increased rate of Processing Errors during procedures performed on the Processor SP caused by Tips in Tip Holder Assemblies for the following products and lots of Extraction Trays.

510(k) Number

K103209 ↗

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

  Class II

  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 Enteric Pathogen Nucleic Acid Test (EP) Open recall

  Class II

  FDA 510(k) K140083 Active Cleared 20 Jun 2014

• Verigene CYP2C19 Nucleic Acid Tes (2C19)

  Class II

  FDA 510(k) K120466 Active Cleared 6 Nov 2012

See all devices from Nanosphere, Inc. →