Product code GNO— Microbiology

COXSACKIE A2 CF ANTIGEN, A4, A10 & A16

Classification name
Antisera, Cf, Coxsackievirus A 1-24, B 1-6
Device class
Class 1
Regulation
21 CFR 866.3145
Advisory panel
Microbiology
Total cleared
1
First cleared
Most recent

Market context for product code GNO

FDA has cleared 1 device under product code GNO, all in 1985, 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 GNO

Recent clearances under product code GNO

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