Product code GNX
- Device name
- Antigens, Cf (Including Cf Control), Influenza Virus A, B, C
- Medical specialty
- Microbiology
- Device class
- 1
- Regulation number
- 866.3330
- Review panel
- MI
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K133411 | ALERE BINAXNOW INFLUENZA A & B CARD | Alere Scarborough, Inc D/B/A Binax, Inc. | 2013-12-05 |
| K132352 | SAS FLUALERT A & B, SAS INFLUENZA A TEST | Sa Scientific , Ltd. | 2013-08-22 |
| K131804 | REMEL XPECT FLU A&B | Remel, Inc. | 2013-07-12 |
| K131599 | QUICK VUE INFLUENZA | Quidel Corporation | 2013-07-05 |
| K131606 | SOFIA INFLUENZA A+B FIA | Quidel Corp. | 2013-07-05 |
| K131619 | QUICKVUE INFLUENZA A+B | Quidel Corp. | 2013-06-28 |
| K123182 | OSOM INFLUENZA A&B TEST MODEL 190 | SEKISUI Diagnostics, LLC | 2012-11-05 |
| K971494 | VIRAZYME INFLUENZA ID TEST FOR INFLUENZA TYPES A AND B VIRUSES | Zymetx, Inc. | 1997-09-10 |
| K924006 | BARTEL PRIMA SYSTEM INFLUENZA A ENZYME IMMUNOASSAY | Baxter Healthcare Corp | 1992-12-29 |
| K901493 | FITC MURINE MONOCLONAL ANTI-INFLUENZA TYPE B | Whittaker Bioproducts, Inc. | 1990-06-27 |
| K893579 | FITC MURINE MONOCLONAL ANTI-INFLUENZA TYPE A | Whittaker Bioproducts, Inc. | 1990-01-16 |
| K884191 | INFLUENZA A IFA TEST FOR DIRECT ANTIGEN DETECTION | Baxter Diagnostics, Inc. | 1988-11-22 |
| K872958 | IMAGEN INFLUENZA VIRUS A AND B TESTMI | Boots-Celltech Diagnostics, Inc. | 1988-02-24 |
| K871231 | ANTIBODY ASSAY FOR DETECTION OF INFLUENZA B | Microscan Div. Baxter Healthcare Corp. | 1987-06-26 |
| K871233 | ANTIBODY ASSAY FOR DETECTION OF INFLUENZA A | Microscan Div. Baxter Healthcare Corp. | 1987-06-26 |
| K843659 | INFLUENZA A2 VIRUS | Institute Virion , Ltd. | 1985-09-26 |
| K843660 | IN FLUENZA B VIRUS | Institute Virion , Ltd. | 1985-09-26 |
| K802931 | INFLUENZA A & B S-ANTIGEN & CONTROLS | Orion Diagnostica, Inc. | 1981-01-12 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 16977977230031 | N/A | Zhengzhou Shiyi Biotech Co., Ltd. | 2025-01-28 |
| 16977977230024 | N/A | Zhengzhou Shiyi Biotech Co., Ltd. | 2025-01-28 |
| 26977977230021 | N/A | Zhengzhou Shiyi Biotech Co., Ltd. | 2025-01-28 |
| 26977977230038 | N/A | Zhengzhou Shiyi Biotech Co., Ltd. | 2025-01-28 |
| 05032384502981 | IMAGEN Influenza Virus A and B | OXOID LIMITED | 2024-12-30 |
| 00855113008722 | ClearFit | LONGEVITI NEURO SOLUTIONS LLC | 2024-03-20 |
| 00855113008661 | Longeviti Convenience Kit 5.0 | LONGEVITI NEURO SOLUTIONS LLC | 2024-03-15 |
| 08033891327514 | CHORUS INFLUENZA A IgG | DIESSE DIAGNOSTICA SENESE SPA | 2024-01-22 |
| 08033891327538 | CHORUS INFLUENZA B IgG | DIESSE DIAGNOSTICA SENESE SPA | 2024-01-22 |
| 00848838063701 | Remel | REMEL, INC. | 2021-11-12 |
| 03848838063708 | Remel | REMEL, INC. | 2021-11-12 |
| 30848838063702 | Remel | REMEL, INC. | 2021-11-12 |
| 00816917022925 | Poly stat | POLYMEDCO, INC. | 2019-04-18 |
| 30014613331469 | QuickVue | QUIDEL CORPORATION | 2019-04-17 |
| 30014613202189 | Sofia | QUIDEL CORPORATION | 2018-11-10 |
| 30014613201830 | QuickVue | QUIDEL CORPORATION | 2018-11-10 |
| 10743816001508 | Status Flu A+B card | PRINCETON BIOMEDITECH CORPORATION | 2018-07-05 |
| 00382902560746 | BD Veritor™ Plus CLIA-Waived Combo Pack | BECTON, DICKINSON AND COMPANY | 2018-05-25 |
| 10743816001478 | BioSign Flu A+B card | PRINCETON BIOMEDITECH CORPORATION | 2018-04-09 |
| 10743816001447 | Status Flu A & B | PRINCETON BIOMEDITECH CORPORATION | 2017-10-13 |
| 20612479225118 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2017-09-29 |
| 20612479226795 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2017-09-29 |
| 10743816001430 | Status Flu A+B Validation Kit | PRINCETON BIOMEDITECH CORPORATION | 2017-05-10 |
| 10743816001416 | Status Flu A+B Nasal Wash/Aspirate Kit | PRINCETON BIOMEDITECH CORPORATION | 2017-04-20 |
| 20608337000065 | OraSure Quick Flu 22-Count Flu A + B Kit | Orasure Technologies, Inc. | 2016-11-10 |
| 00304040019771 | Henry Schein | HENRY SCHEIN, INC. | 2016-09-24 |
| 10743816001218 | Status Flu A+B card | PRINCETON BIOMEDITECH CORPORATION | 2016-09-23 |
| 10743816001201 | BioSign Flu A+B card | PRINCETON BIOMEDITECH CORPORATION | 2016-09-23 |
| 10743816001195 | Status Flu A+B card | PRINCETON BIOMEDITECH CORPORATION | 2016-09-23 |
| 10743816001188 | BioSign Flu A+B card | PRINCETON BIOMEDITECH CORPORATION | 2016-09-23 |