Product code NZS— Microbiology

C. ALBICANS PNA FISH

Classification name: Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Yeast
Device class: Class 1
Regulation: 21 CFR 866.2660
Advisory panel: Microbiology
Total cleared: 3
First cleared: 2010-01-19
Most recent: 2010-07-15

FDA classification definition

“Indicated as a qualitative nucleic acid hybridization assay intended for identification of candida albicans from blood cultures with yeast.”
— U.S. Food and Drug Administration, device classification record for product code NZS under 21 CFR 866.2660, via openFDA

Market context for product code NZS

FDA has cleared 3 devices under product code NZS, all in 2010, 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.

Top applicants under product code NZS

Advandx, Inc.3 clearances

Recent clearances under product code NZS

K093024 — YEAST TRAFFIC LIGHT PNA FISHAdvandx, Inc.·2010-07-15
K092784 — C. ALBICANS/C. GLABRATA PNA FISHAdvandx, Inc.·2010-03-12
K092655 — C. ALBICANS PNA FISHAdvandx, Inc.·2010-01-19

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