Product code NZS

Device name: Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Yeast
Medical specialty: Microbiology
Device class: 1
Regulation number: 866.2660
Review panel: MI
Implant: N
Life sustaining/supporting: N
GMP exempt: N
Third party review: N
Summary malfunction reporting: Eligible
Definition: Indicated as a qualitative nucleic acid hybridization assay intended for identification of candida albicans from blood cultures with yeast.
Source: FDA openFDA device classification dataset

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K093024	YEAST TRAFFIC LIGHT PNA FISH	Advandx, Inc.	2010-07-15
K092784	C. ALBICANS/C. GLABRATA PNA FISH	Advandx, Inc.	2010-03-12
K092655	C. ALBICANS PNA FISH	Advandx, Inc.	2010-01-19

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