Device |
devices detecting influenza a, b, and c virus antigens |
Regulation Description |
Influenza virus antigen detection test system. |
Definition |
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. |
Physical State |
Devices detecting influenza A, B, and C virus antigens are in vitro diagnostic devices that consist of reagents and associated instrumentation for the detection and identification of influenza virus antigens |
Technical Method |
A qualitative in vitro diagnostic assay that detects and identifies influenza virus antigens |
Target Area |
In vitro diagnostic device |
Regulation Medical Specialty |
Microbiology |
Review Panel |
Microbiology |
Product Code | PSZ |
Premarket Review |
Office of In Vitro Diagnostics
(OHT7)
Division of Microbiology Devices
(DMD)
|
Submission Type |
510(k)
|
Regulation Number |
866.3328
|
Device Class |
2
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Eligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Third Party Review |
Not Third Party Eligible |