DeviceClearance

Product code NXX— Microbiology

S. AUREUS PNA FISH

Classification name
Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Staphylococcus Aureus
Device class
Class 1
Regulation
21 CFR 866.3700
Advisory panel
Microbiology
Total cleared
4
First cleared
Most recent

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).”

— U.S. Food and Drug Administration, device classification record for product code NXX under 21 CFR 866.3700, via openFDA

Market context for product code NXX

FDA has cleared 4 devices under product code NXX between 2006 and 2012, filed by 1 applicant company. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Clearances per year

Top applicants under product code NXX

Recent clearances under product code NXX

Data sourced from openFDA. This site is unofficial and independent of the FDA.