|
Device |
devices detecting influenza a, b, and c virus antigens |
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. |
Product Code | PSZ |
Regulation Number |
866.3328
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
ACCESS BIO, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ALERE SCARBOROUGH, INC D/B/A BINAX, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ALERE SCARBOROUGH, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
BD |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
BECTON DICKINSON & CO. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
BECTON DICKINSON AND CO. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BECTON DICKINSON AND COMPANY |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
BECTON DICKINSON, AND CO. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BECTON, DICKINSON & CO. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
BECTON, DICKINSON AND COMPANY |
|
SUBSTANTIALLY EQUIVALENT
|
8
|
BINAX, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GENZYME CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
INVERNESS MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MERIDIAN BIOSCIENCE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
PRINCETON BIOMEDITECH CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
QUIDEL CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
QUIDEL CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
RESPONSE BIOMEDICAL CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SA SCIENTIFIC, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SEKISUI DIAGNOSTICS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
THERMO FISHER SCIENTIFIC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
|
|
|