NXX — Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Staphylococcus Aureus Class I

FDA Device Classification

Classification Details

Product Code: NXX
Device Class: Class I
Regulation Number: 866.3700
Submission Type
Review Panel: MI
Medical Specialty: Microbiology
Implant: No

Definition

The s. Aureus pna fish is a qualitative nucleic acid hybridization assay intended for presumptive identification of staphylococcus aureus from blood cultures with gram-positive cocci in clusters (gpcc). This device is not exempt per 21 cfr part 866.9(c)(6).

Recent 510(k) Clearances

K-Number	Applicant	Device Name	Date
K113371	advandx	STAPHYLOCOCCUS QUICKFISH BC	April 3, 2012
K092166	advandx	S. AUREUS/CNS PNA FISH, MODEL KT005	November 23, 2009
K091827	advandx	S. AUREUS PNA FISH	August 18, 2009
K060099	advandx	S. AUREUS PNA FISH	May 8, 2006