DeviceClearance

Product code GNH— Microbiology

AMIZYME-SCHISTOSOMA SPP. TEST KIT

Classification name
Antigen, Fluorescent Antibody Test, Schistosoma Mansoni
Device class
Class 1
Regulation
21 CFR 866.3600
Advisory panel
Microbiology
Total cleared
2
First cleared
Most recent

Market context for product code GNH

FDA has cleared 2 devices under product code GNH, all in 1984, 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 GNH

Recent clearances under product code GNH

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