DeviceClearance

Product code GNP— Microbiology

AMIZYME-EBV TEST KIT

Classification name
Antiserum, Cf, Epstein-Barr Virus
Device class
Class 1
Regulation
21 CFR 866.3235
Advisory panel
Microbiology
Total cleared
20
First cleared
Most recent

Market context for product code GNP

FDA has cleared 20 devices under product code GNP between 1977 and 2002, filed by 13 applicant companies. 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 GNP

Recent clearances under product code GNP

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