FDA Product Code PSZ: Devices Detecting Influenza A, B, And C Virus Antigens
An Influenza Virus Antigen Detection Test System Is A Device Intended For The Qualitative Detection Of Influenza Viral Antigens Directly From Clinical Specimens In Patients With Signs And Symptoms Of Respiratory Infection.
Leading manufacturers include Bd, SEKISUI Diagnostics, LLC and Innovita (Tangshan) Biological Technology Co., Ltd..
FDA 510(k) Cleared Devices Detecting Influenza A, B, And C Virus Antigens Devices (Product Code PSZ)
About Product Code PSZ - Regulatory Context
510(k) Submission Activity
72 total 510(k) submissions under product code PSZ since 1998, with 72 receiving FDA clearance (average review time: 107 days).
Submission volume has increased in recent years - 3 submissions in the last 24 months compared to 2 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under PSZ have taken an average of 224 days to reach a decision - up from 101 days historically. Manufacturers should account for longer review timelines in current project planning.
PSZ devices are reviewed by the Microbiology panel. Browse all Microbiology devices →