GNT · Antigens, Ha (Including Ha Control), Influenza Virus A, B, C
Microbiology · 21 CFR 866.3330 · Class 1
Overview
| Product Code | GNT |
|---|---|
| Device Name | Antigens, Ha (Including Ha Control), Influenza Virus A, B, C |
| Regulation | 21 CFR 866.3330 |
| Device Class | Class 1 |
| Review Panel | Microbiology |
Identification
Influenza virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to influenza in serum. The identification aids in the diagnosis of influenza (flu) and provides epidemiological information on influenza. Influenza is an acute respiratory tract disease, which is often epidemic.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.
Recent Cleared Devices (5 of 5)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K950838 | VIRAZYME CULTURE CONFIRMATION SCREEN FOR INFLUENZA AND PARAINFLUENZA VIRUSES | Zymetx, Inc. | Jun 17, 1996 | SESE |
| K913828 | QTEST INFLUENZA A | Bd Becton Dickinson Vacutainer Systems Preanalytic | Sep 23, 1991 | SESE |
| K902609 | DIRECTIGEN FLU A | Bd Becton Dickinson Vacutainer Systems Preanalytic | Sep 10, 1990 | SESE |
| K780275 | INFLUENZA HA ANTIGEN A/USSR | Flow Laboratories, Inc. | Feb 28, 1978 | SESE |
| K780272 | INFLUENZA HA ANTIGEN | Flow Laboratories, Inc. | Feb 28, 1978 | SESE |
Top Applicants
- Bd Becton Dickinson Vacutainer Systems Preanalytic — 2 clearances
- Flow Laboratories, Inc. — 2 clearances
- Zymetx, Inc. — 1 clearance
