NXX

Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Staphylococcus Aureus

Product code

NXX

Device name

Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Staphylococcus Aureus

Device class

Class 1

21 CFR

21 CFR 866.3700

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

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).

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