DeviceClearance

Product code GNE— Microbiology

DAT TEST FOR CHAGAS' DISEASE

Classification name
Antigen, Latex Agglutination, T. Cruzi
Device class
Class 1
Regulation
21 CFR 866.3870
Advisory panel
Microbiology
Total cleared
1
First cleared
Most recent

Market context for product code GNE

FDA has cleared 1 device under product code GNE, 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 GNE

Recent clearances under product code GNE

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