OAH — Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Enterococcus Faecalis Class I

FDA Device Classification

Classification Details

Product Code: OAH
Device Class: Class I
Regulation Number: 866.3740
Submission Type
Review Panel: MI
Medical Specialty: Microbiology
Implant: No

Definition

E. Faecalis pna fish is a qualitative nucleic acid hybridization assay intended for the identification of enterococcus faecalis and other enterococci (oe) from blood cultures showing Gram-positive cocci in pairs and chains.

Recent 510(k) Clearances

K-Number	Applicant	Device Name	Date
K121991	advandx	ENTEROCOCCUS QUICKFISH BC	January 7, 2013
K083074	advandx	AVANDX E. FAECALIS/OE PNA FISH CULTURE IDENTIFICATION KIT	July 24, 2009
K082612	advandx	GBS PNA FISH	May 5, 2009
K063127	advandx	ENTEROCOCCUS FAECALIS PNA FISH	December 22, 2006