GNW — Antisera, Cf, Influenza Virus A, B, C Class I
FDA Device Classification
Classification Details
- Product Code
- GNW
- Device Class
- Class I
- Regulation Number
- 866.3330
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K092882 | diagnostic hybrids | D3 FASTPOINT L-DFA INFLUENZA A/INFLUENZA B VIRUS IDENTIFICATION KIT | October 21, 2009 |
| K092300 | diagnostic hybrids | MODIFICATION TO D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KIT | August 28, 2009 |
| K081746 | diagnostic hybrids | D3 DUET DFA INFLUENZA A/RESPIRATORY VIRUS SCREENING KIT | December 23, 2008 |
| K061101 | diagnostic hybrids | D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KIT | November 20, 2006 |
| K022713 | diagnostic hybrids | DFA RESPIRATORY VIRUS SCREENING & ID KIT | December 18, 2002 |
| K003204 | intracel | BARTELS VIRAL RESPIRATORY SCREENING AND IDENTIFICATION KIT | November 7, 2000 |
| K974302 | light diagnostics | LIGHT DIAGNOSTICS SIMULFLUOR FLU A/FLU B | April 8, 1998 |
| K973954 | dako diagnostics | IMAGEN RESPIRATORY SCREEN | December 22, 1997 |
| K962037 | dako diagnostics | IMAGEN RESPIRATORY SCREEN | December 26, 1996 |
| K942172 | neogenex | INFLUENZA A ANTIGEN TEST | July 6, 1994 |
| K942174 | neogenex | INFLUENZA B ANITGEN TEST | June 30, 1994 |
| K913351 | gull laboratories | INFLUENZA MAB TEST/INFLUENZA A TEST | December 17, 1991 |
| K913214 | gull laboratories | INFLUENZA MAB TEST/INFLUENZA B TEST | December 13, 1991 |
| K896635 | baxter healthcare | VIRAL RESPIRATORY INDIRECT FLUORES. MONO. ANTIBODY | February 2, 1990 |
| K872694 | sita | YNFLUENZA A VIRUS CF ANTIGEN AND CONTROL ANTIGEN | September 18, 1987 |
| K872693 | sita | INFLUENZA B VIRUS CF ANTIGEN AND CONTROL ANTIGEN | September 18, 1987 |