OAH

Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Enterococcus Faecalis

Product code

OAH

Device name

Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Enterococcus Faecalis

Device class

Class 1

21 CFR

21 CFR 866.3740

Medical specialty

Microbiology

Marketing pathway

510(K) Exempt

510(k) clearances (all years, FDA)

4 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).