Simplexa C. Difficile Universal Direct

No FDA recalls on record, checked 10 Oct 2026.

510(k) Number

K113433 ↗

FDA Product Code

OMN

Device Class

Class I

Regulation

21 CFR Part 866.2660

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

• HerpeSelect Express IgG, HerpeSelect Express Controls, Models RT0920G, RT0950

  Class II

  FDA 510(k) K071510 Active Cleared 24 Sep 2007

• Plexus Herpeselect 1 and 2 Igg (with Plexus Tm Software), Model MP0900G

  Class II

  FDA 510(k) K071511 Active Cleared 5 Oct 2007

• Simplexa Flu a/B & Rsv

  Class II

  FDA 510(k) K102170 Active Cleared 24 Nov 2010

• Simplexa Hsv 1&2 Direct/Positive Control Pack

  Class II

  FDA 510(k) K141458 Active Cleared 1 Jul 2014

• Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack

  Class II

  FDA 510(k) K150962 Active Cleared 28 Aug 2015

• 3M Integrated Cycler (110V) & (220V)

  Class II

  FDA 510(k) K102314 Active Cleared 29 Oct 2010

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