Verigene® Reader (Refurbished) 10-0000-02R

No FDA recalls on record, checked 22 Oct 2026.

Trade Name

Verigene® Reader (Refurbished)

Generic Name

Multiplex analyser IVD, laboratory

Model / Reference

10-0000-02R

Primary DI / UDI-DI

00857573006393

FDA Product Code

NSU, OOI

GMDN Term

Multiplex analyser IVD, laboratory

Device Class

Class II

Regulation Number

862.2570

GUDID distribution status

Not in Commercial Distribution

• 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 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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