Product code GNG— Microbiology

COXSACKIE B SERIES CF ANTIGENS

Classification name
Antigens, Cf (Including Cf Control), Coxsackievirus A 1-24, B 1-6
Device class
Class 1
Regulation
21 CFR 866.3145
Advisory panel
Microbiology
Total cleared
2
First cleared
Most recent

Market context for product code GNG

FDA has cleared 2 devices under product code GNG between 1985 and 1992, filed by 2 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 GNG

Recent clearances under product code GNG

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