GNW · Antisera, Cf, Influenza Virus A, B, C
Microbiology · 21 CFR 866.3330 · Class 1
Overview
| Product Code | GNW |
|---|---|
| Device Name | Antisera, Cf, 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 (16 of 16)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K092882 | D3 FASTPOINT L-DFA INFLUENZA A/INFLUENZA B VIRUS IDENTIFICATION KIT | Diagnostic Hybrids, Inc. | Oct 21, 2009 | SESE |
| K092300 | MODIFICATION TO D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KIT | Diagnostic Hybrids, Inc. | Aug 28, 2009 | SESE |
| K081746 | D3 DUET DFA INFLUENZA A/RESPIRATORY VIRUS SCREENING KIT | Diagnostic Hybrids, Inc. | Dec 23, 2008 | SESE |
| K061101 | D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KIT | Diagnostic Hybrids, Inc. | Nov 20, 2006 | SESE |
| K022713 | DFA RESPIRATORY VIRUS SCREENING & ID KIT | Diagnostic Hybrids, Inc. | Dec 18, 2002 | SESE |
| K003204 | BARTELS VIRAL RESPIRATORY SCREENING AND IDENTIFICATION KIT | Intracel Corp. | Nov 7, 2000 | SESE |
| K974302 | LIGHT DIAGNOSTICS SIMULFLUOR FLU A/FLU B | Light Diagnostics | Apr 8, 1998 | SESE |
| K973954 | IMAGEN RESPIRATORY SCREEN | Dako Diagnostics , Ltd. | Dec 22, 1997 | SESE |
| K962037 | IMAGEN RESPIRATORY SCREEN | Dako Diagnostics , Ltd. | Dec 26, 1996 | SESE |
| K942172 | INFLUENZA A ANTIGEN TEST | Neogenex | Jul 6, 1994 | SESE |
| K942174 | INFLUENZA B ANITGEN TEST | Neogenex | Jun 30, 1994 | SESE |
| K913351 | INFLUENZA MAB TEST/INFLUENZA A TEST | Gull Laboratories, Inc. | Dec 17, 1991 | SESE |
| K913214 | INFLUENZA MAB TEST/INFLUENZA B TEST | Gull Laboratories, Inc. | Dec 13, 1991 | SESE |
| K896635 | VIRAL RESPIRATORY INDIRECT FLUORES. MONO. ANTIBODY | Baxter Healthcare Corp | Feb 2, 1990 | SESE |
| K872694 | YNFLUENZA A VIRUS CF ANTIGEN AND CONTROL ANTIGEN | Sita, Inc. | Sep 18, 1987 | SESE |
| K872693 | INFLUENZA B VIRUS CF ANTIGEN AND CONTROL ANTIGEN | Sita, Inc. | Sep 18, 1987 | SESE |
Top Applicants
- Diagnostic Hybrids, Inc. — 5 clearances
- Dako Diagnostics , Ltd. — 2 clearances
- Gull Laboratories, Inc. — 2 clearances
- Neogenex — 2 clearances
- Sita, Inc. — 2 clearances
