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.
| Device Type ID | 3579 |
| Device Name | Devices Detecting Influenza A, B, And C Virus Antigens |
| 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 Description | Influenza Virus Antigen Detection Test System. |
| Regulation Medical Specialty | Microbiology |
| Review Panel | Microbiology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 866.3328 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PSZ |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3579 |
| Device | Devices Detecting Influenza A, B, And C Virus Antigens |
| Product Code | PSZ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Influenza Virus Antigen Detection Test System. |
| CFR Regulation Number | 866.3328 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ALERE SCARBOROUGH, INC. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
BD | ||
SUBSTANTIALLY EQUIVALENT | 6 | |
BECTON DICKINSON AND COMPANY | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
BECTON, DICKINSON & CO. | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
BIOMEDICA DIAGNOSTICS INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MERIDIAN BIOSCIENCE, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MERIDIAN CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PRINCETON BIOMEDITECH CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
QUIDEL CORP. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
QUIDEL CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
| Device Problems | |
|---|---|
False Negative Result | 1 |
| Total Device Problems | 1 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Quidel Corporation | II | Mar-26-2018 |