Panels › Microbiology › Product code GNW · Class 1
Antisera, Cf, Influenza Virus A, B, C
Regulation 866.3330
0510(k)s in 12 months (16 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in GNW
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 21, 2009 | K092882 | D3 FASTPOINT L-DFA INFLUENZA A/INFLUENZA B VIRUS IDENTIFICATION KIT Diagnostic Hybrids, Inc. | GNW |
| Aug 28, 2009 | K092300 | MODIFICATION TO D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KIT Diagnostic Hybrids, Inc. | GNW |
| Dec 23, 2008 | K081746 | D3 DUET DFA INFLUENZA A/RESPIRATORY VIRUS SCREENING KIT Diagnostic Hybrids, Inc. | GNW |
| Nov 20, 2006 | K061101 | D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KIT Diagnostic Hybrids, Inc. | GNW |
| Dec 18, 2002 | K022713 | DFA RESPIRATORY VIRUS SCREENING & ID KIT Diagnostic Hybrids, Inc. | GNW |
| Nov 7, 2000 | K003204 | BARTELS VIRAL RESPIRATORY SCREENING AND IDENTIFICATION KIT Intracel Corp. | GNW |
| Apr 8, 1998 | K974302 | LIGHT DIAGNOSTICS SIMULFLUOR FLU A/FLU B Light Diagnostics | GNW |
| Dec 22, 1997 | K973954 | IMAGEN RESPIRATORY SCREEN Dako Diagnostics , Ltd., GB | GNW |
| Dec 26, 1996 | K962037 | IMAGEN RESPIRATORY SCREEN Dako Diagnostics , Ltd., GB | GNW |
| Jul 6, 1994 | K942172 | INFLUENZA A ANTIGEN TEST Neogenex | GNW |
| Jun 30, 1994 | K942174 | INFLUENZA B ANITGEN TEST Neogenex | GNW |
| Dec 17, 1991 | K913351 | INFLUENZA MAB TEST/INFLUENZA A TEST Gull Laboratories, Inc. | GNW |
| Dec 13, 1991 | K913214 | INFLUENZA MAB TEST/INFLUENZA B TEST Gull Laboratories, Inc. | GNW |
| Feb 2, 1990 | K896635 | VIRAL RESPIRATORY INDIRECT FLUORES. MONO. ANTIBODY Baxter Healthcare Corp | GNW |
| Sep 18, 1987 | K872694 | YNFLUENZA A VIRUS CF ANTIGEN AND CONTROL ANTIGEN Sita, Inc. | GNW |
| Sep 18, 1987 | K872693 | INFLUENZA B VIRUS CF ANTIGEN AND CONTROL ANTIGEN Sita, Inc. | GNW |
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