mecA XpressFISH® KT601

Trade Name

mecA XpressFISH®

Generic Name

Staphylococcus aureus culture isolate antigen IVD, reagent

Model / Ref / Catalog

KT601

Primary DI / UDI-DI

00812125010082

FDA Product Code

MYI

GMDN Term

Staphylococcus aureus culture isolate antigen IVD, reagent

Device Class

Class II

Regulation Number

866.1640

GUDID distribution status

In Commercial Distribution

Category: Staphylococcus aureus culture isolate antigen IVD, reagent

• C. Albicans Pna Fish

  Class I

  FDA 510(k) K092655 Active Cleared 19 Jan 2010

• E. Coli Pna Fish

  Class I

  FDA 510(k) K082068 Active Cleared 25 Jun 2009

• E.coli/P. Aeruginosa Pna Fish

  Class I

  FDA 510(k) K092236 Active Cleared 16 Dec 2009

• Gbs Pna Fish

  Class I

  FDA 510(k) K082612 Active Cleared 5 May 2009

• Gnr Traffic Light Pna Fish

  Class I

  FDA 510(k) K101558 Active Cleared 16 Dec 2010

• Ek/P. Aeruginosa Pna Fish

  Class I

  FDA 510(k) K092393 Active Cleared 1 Sep 2009

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