PSZ · Class II · 21 CFR 866.3328

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 Becton, Dickinson and Company, Becton, Dickinson & CO and Quidel Corp..

72
Total
72
Cleared
107d
Avg days
1998
Since
72 devices
49–72 of 72
Cleared Dec 20, 1999
ROCHE DIAGNOSTICS INFLUENZA A/B RAPID TEST
K993048
Roche Diagnostics Corp.
Microbiology · 101d
Cleared Sep 24, 1999
QUICKVUE INFLUENZA A/B TEST
K991633
Quidel Corp.
Microbiology · 135d