FDA Product Code GQG: Antigen, Cf (including Cf Controls), Respiratory Syncytial Virus
Leading manufacturers include Nano-Ditech Corporation and Hangzhou Clongene Biotech Co., Ltd..
FDA 510(k) Cleared Antigen, Cf (including Cf Controls), Respiratory Syncytial Virus Devices (Product Code GQG)
About Product Code GQG - Regulatory Context
510(k) Submission Activity
32 total 510(k) submissions under product code GQG since 1977, with 32 receiving FDA clearance (average review time: 105 days).
Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under GQG have taken an average of 151 days to reach a decision - up from 102 days historically. Manufacturers should account for longer review timelines in current project planning.
GQG devices are reviewed by the Microbiology panel. Browse all Microbiology devices →