Antisera, Cf, Influenza Virus A, B, C
The Influenza Virus A, B, and C CF (Complement Fixation) Antisera are reference reagents used in complement fixation tests to detect and type influenza virus strains in clinical and epidemiological settings. It is classified as FDA Class 1 (lowest risk) and is subject only to general controls. The product code is GNW, regulated under 21 CFR 866.3330 in the Microbiology specialty.
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Basic Information
- Product Code
- GNW
- Device Class
- FDA class 1
- Regulation Number
- 866.3330
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 16 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K092882 | D3 FASTPOINT L-DFA INFLUENZA A/INFLUENZA B VIRUS IDENTIFICATION KIT | Oct 21, 2009 | Substantially Equivalent | Diagnostic Hybrids, Inc. |
| K092300 | MODIFICATION TO D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KIT | Aug 28, 2009 | Substantially Equivalent | Diagnostic Hybrids, Inc. |
| K081746 | D3 DUET DFA INFLUENZA A/RESPIRATORY VIRUS SCREENING KIT | Dec 23, 2008 | Substantially Equivalent | Diagnostic Hybrids, Inc. |
| K061101 | D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KIT | Nov 20, 2006 | Substantially Equivalent | Diagnostic Hybrids, Inc. |
| K022713 | DFA RESPIRATORY VIRUS SCREENING & ID KIT | Dec 18, 2002 | Substantially Equivalent | Diagnostic Hybrids, Inc. |
| K003204 | BARTELS VIRAL RESPIRATORY SCREENING AND IDENTIFICATION KIT | Nov 07, 2000 | Substantially Equivalent | Intracel Corp. |
| K974302 | LIGHT DIAGNOSTICS SIMULFLUOR FLU A/FLU B | Apr 08, 1998 | Substantially Equivalent | Light Diagnostics |
| K973954 | IMAGEN RESPIRATORY SCREEN | Dec 22, 1997 | Substantially Equivalent | Dako Diagnostics , Ltd. |
| K962037 | IMAGEN RESPIRATORY SCREEN | Dec 26, 1996 | Substantially Equivalent | Dako Diagnostics , Ltd. |
| K942172 | INFLUENZA A ANTIGEN TEST | Jul 06, 1994 | Substantially Equivalent | Neogenex |
| K942174 | INFLUENZA B ANITGEN TEST | Jun 30, 1994 | Substantially Equivalent | Neogenex |
| K913351 | INFLUENZA MAB TEST/INFLUENZA A TEST | Dec 17, 1991 | Substantially Equivalent | Gull Laboratories, Inc. |
| K913214 | INFLUENZA MAB TEST/INFLUENZA B TEST | Dec 13, 1991 | Substantially Equivalent | Gull Laboratories, Inc. |
| K896635 | VIRAL RESPIRATORY INDIRECT FLUORES. MONO. ANTIBODY | Feb 02, 1990 | Substantially Equivalent | Baxter Healthcare Corp |
| K872694 | YNFLUENZA A VIRUS CF ANTIGEN AND CONTROL ANTIGEN | Sep 18, 1987 | Substantially Equivalent | Sita, Inc. |
| K872693 | INFLUENZA B VIRUS CF ANTIGEN AND CONTROL ANTIGEN | Sep 18, 1987 | Substantially Equivalent | Sita, Inc. |
FEI Numbers
This FDA classification entry is associated with 8 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 8 registration numbers. Click on an entry to view related FDA registrations.