Simplexa Hsv 1&2 Direct

No FDA recalls on record, checked 10 Oct 2026.

De Novo Number

DEN130049 ↗

FDA Product Code

PGH

Device Class

Class II

Regulation

21 CFR Part 866.3307

Advisory Committee

Microbiology

FDA Decision

DENG De Novo granted

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

  Class II

  FDA 510(k) K071510 Active Cleared 24 Sep 2007

• Simplexa C. Difficile Universal Direct

  Class I

  FDA 510(k) K113433 Active Cleared 4 Apr 2012

• 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

See all devices from Focus Diagnostics, Inc. →