NZS — Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Yeast Class I

FDA Device Classification

Classification Details

Product Code
NZS
Device Class
Class I
Regulation Number
866.2660
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No

Definition

Indicated as a qualitative nucleic acid hybridization assay intended for identification of candida albicans from blood cultures with yeast.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K093024advandxYEAST TRAFFIC LIGHT PNA FISHJuly 15, 2010
K092784advandxC. ALBICANS/C. GLABRATA PNA FISHMarch 12, 2010
K092655advandxC. ALBICANS PNA FISHJanuary 19, 2010