Panels › Microbiology › Product code GNX · Class 1
Antigens, Cf (Including Cf Control), Influenza Virus A, B, C
Regulation 866.3330
0510(k)s in 12 months (18 all time)
0recalls in 12 months (10 all time)
7recalls that name a 510(k)
Top companies in GNX
| Company | 510(k)s | Recalls |
|---|---|---|
| Binax, Inc. dba IMPD | 0 | 4 |
| Quidel Corp. | 3 | 1 |
| Princeton Biomeditech Corp | 0 | 3 |
| Institute Virion , Ltd. | 2 | 0 |
| Microscan Div. Baxter Healthcare Corp. | 2 | 0 |
| Remel, Inc. | 1 | 1 |
| Whittaker Bioproducts, Inc. | 2 | 0 |
| Alere Scarborough, Inc D/B/A Binax, Inc. | 1 | 0 |
| Baxter Diagnostics, Inc. | 1 | 0 |
| Baxter Healthcare Corp | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 5, 2013 | K133411 | ALERE BINAXNOW INFLUENZA A & B CARD Alere Scarborough, Inc D/B/A Binax, Inc. | GNX |
| Aug 22, 2013 | K132352 | SAS FLUALERT A & B, SAS INFLUENZA A TEST Sa Scientific , Ltd. | GNX |
| Jul 12, 2013 | K131804 | REMEL XPECT FLU A&B Remel, Inc. | GNX |
| Jul 5, 2013 | K131606 | SOFIA INFLUENZA A+B FIA Quidel Corp. | GNX |
| Jul 5, 2013 | K131599 | QUICK VUE INFLUENZA Quidel Corporation | GNX |
| Jun 28, 2013 | K131619 | QUICKVUE INFLUENZA A+B Quidel Corp. | GNX |
| Nov 5, 2012 | K123182 | OSOM INFLUENZA A&B TEST MODEL 190 SEKISUI Diagnostics, LLC | GNX |
| Sep 10, 1997 | K971494 | VIRAZYME INFLUENZA ID TEST FOR INFLUENZA TYPES A AND B VIRUSES Zymetx, Inc. | GNX |
| Dec 29, 1992 | K924006 | BARTEL PRIMA SYSTEM INFLUENZA A ENZYME IMMUNOASSAY Baxter Healthcare Corp | GNX |
| Jun 27, 1990 | K901493 | FITC MURINE MONOCLONAL ANTI-INFLUENZA TYPE B Whittaker Bioproducts, Inc. | GNX |
| Jan 16, 1990 | K893579 | FITC MURINE MONOCLONAL ANTI-INFLUENZA TYPE A Whittaker Bioproducts, Inc. | GNX |
| Nov 22, 1988 | K884191 | INFLUENZA A IFA TEST FOR DIRECT ANTIGEN DETECTION Baxter Diagnostics, Inc. | GNX |
| Feb 24, 1988 | K872958 | IMAGEN INFLUENZA VIRUS A AND B TESTMI Boots-Celltech Diagnostics, Inc., GB | GNX |
| Jun 26, 1987 | K871233 | ANTIBODY ASSAY FOR DETECTION OF INFLUENZA A Microscan Div. Baxter Healthcare Corp. | GNX |
| Jun 26, 1987 | K871231 | ANTIBODY ASSAY FOR DETECTION OF INFLUENZA B Microscan Div. Baxter Healthcare Corp. | GNX |
| Sep 26, 1985 | K843660 | IN FLUENZA B VIRUS Institute Virion , Ltd. | GNX |
| Sep 26, 1985 | K843659 | INFLUENZA A2 VIRUS Institute Virion , Ltd. | GNX |
| Jan 12, 1981 | K802931 | INFLUENZA A & B S-ANTIGEN & CONTROLS Orion Diagnostica, Inc. | GNX |
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