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| Product | Model | Company | Device type |
|---|---|---|---|
| Acucy Influenza A&B Control KitSekisui Diagnostics, LLCInfluenza A/B virus antigen IVD, control | 1011 | Sekisui Diagnostics, LLC | Influenza A/B virus antigen IVD, control |
| AimStep Flu A&B Test KitGermaine Laboratories, IncInfluenza A/B virus antigen IVD, kit, rapid ICT, clinical | 74425 | Germaine Laboratories, Inc | Influenza A/B virus antigen IVD, kit, rapid ICT, clinical |
| BinaxNOW RSV Control Swab KitAlere Scarborough, Inc.Respiratory syncytial virus (RSV) antigen IVD, control | 430-080 | Alere Scarborough, Inc. | Respiratory syncytial virus (RSV) antigen IVD, control |
| BinaxNOW Streptococcus pneumoniae Antigen CardAlere Scarborough, Inc.Streptococcus pneumoniae antigen IVD, kit, rapid ICT, clinical | 710-000 | Alere Scarborough, Inc. | Streptococcus pneumoniae antigen IVD, kit, rapid ICT, clinical |
| BioSign Flu A+B Nasal Wash/Aspirate KitPrinceton Biomeditech CorporationInfluenza A/B virus antigen IVD, reagent | BSP-510AS-07 | Princeton Biomeditech Corporation | Influenza A/B virus antigen IVD, reagent |
| IMAGEN Influenza Virus A and BOxoid LimitedInfluenza A/B virus antigen IVD, kit, fluorescent immunoassay | K610511-2 | Oxoid Limited | Influenza A/B virus antigen IVD, kit, fluorescent immunoassay |
| IMAGEN RESPIRATORY SCREEN POS CON SLIDEOxoid LimitedMultiple-genus respiratory virus antigen IVD, control | S612130-2 | Oxoid Limited | Multiple-genus respiratory virus antigen IVD, control |
| ImmunoCard STAT! FLU A&B Nasopharyngeal Wash/Aspriate KitMeridian Bioscience, Inc.Influenza A/B virus antigen IVD, kit, rapid ICT, clinical | 781130 | Meridian Bioscience, Inc. | Influenza A/B virus antigen IVD, kit, rapid ICT, clinical |
| Influenza A Negative ControlBion Enterprises, Ltd.Influenza A virus immunoglobulin G (IgG) antibody IVD, control | IAN-1110 | Bion Enterprises, Ltd. | Influenza A virus immunoglobulin G (IgG) antibody IVD, control |
| Influenza A Virus Antigen Substrate, 12 wells, For IFA Test SystemBion Enterprises, Ltd.Influenza A virus immunoglobulin G (IgG) antibody IVD, reagent | IA-1112 | Bion Enterprises, Ltd. | Influenza A virus immunoglobulin G (IgG) antibody IVD, reagent |
| RSV Positive ControlMeridian Bioscience, Inc.Influenza virus/respiratory syncytial virus (RSV) antigen IVD, control | 751110 | Meridian Bioscience, Inc. | Influenza virus/respiratory syncytial virus (RSV) antigen IVD, control |
| WELLlife™Wondfo USA Co., Ltd.Multiple-genus respiratory virus antigen IVD, control | WFLUAB-CON-1 | Wondfo USA Co., Ltd. | Multiple-genus respiratory virus antigen IVD, control |
| WELLlife™Wondfo USA Co., Ltd.Multiple-genus respiratory virus antigen IVD, control | WCOVFLU-CON-1 | Wondfo USA Co., Ltd. | Multiple-genus respiratory virus antigen IVD, control |