NZS

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

Product code

NZS

Device name

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

Device class

Class 1

21 CFR

21 CFR 866.2660

Medical specialty

Microbiology

Marketing pathway

510(K) Exempt

510(k) clearances (all years, FDA)

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

FDA classification definition

Indicated as a qualitative nucleic acid hybridization assay intended for identification of candida albicans from blood cultures with yeast.

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