Product code GQG
- Device name
- Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus
- Medical specialty
- Microbiology
- Device class
- 1
- Regulation number
- 866.3480
- 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 |
|---|---|---|---|
| K253318 | Clungene RSV Antigen Rapid Test | Hangzhou Clongene Biotech Co., Ltd. | 2026-01-30 |
| K240280 | Nano-Check™ RSV Test | Nano-Ditech Corporation | 2024-07-30 |
| K162911 | Sofia RSV FIA on Sofia 2 analyzer | Quidel Corporation | 2017-02-22 |
| K133140 | BD VERITOR SYSTEM FOR THE RAPID DETECTION OF RSV | Becton, Dickinson & CO | 2013-11-15 |
| K132456 | BD VERITOR (TM) SYSTEM FOR RAPID DETECTION OF RSV | Becton, Dickinson and Company | 2013-11-07 |
| K130398 | SOFIA(R) RSV FIA | Quidel Corp. | 2013-08-13 |
| K121633 | BD VERITOR(TM) SYSTEM FOR THE RAPID DETECTION OF RSV | Becton, Dickinson and Company | 2012-09-18 |
| K101918 | QUICKVUE RSV 10 | Quidel Corp. | 2010-09-24 |
| K101514 | BD DIRECTIGEN EZ RSV | Becton, Dickinson & CO | 2010-07-09 |
| K091235 | RAMP RSV ASSAY | Response Biomedical Corp. | 2009-07-24 |
| K070747 | QUICK VUE RSV TEST, MODELS 20193, 20199 | Quidel Corp. | 2007-04-23 |
| K041445 | IMMUNOCARD STAT! RSV MODEL #750630 | Meridian Bioscience, Inc. | 2004-08-13 |
| K032166 | BINAX NOW RSV TEST, MODEL 430-000 AND BINAX NOW NASOPHARYNGEAL SWAB ACCESSORY PACK, MODEL 400-065 | Binax, Inc. | 2003-10-21 |
| K022845 | SAS RSV TEST | Sa Scientific, Inc. | 2003-01-29 |
| K023779 | RSV OIA | Thermo Biostar, Inc. | 2003-01-14 |
| K022133 | BD DIRECTIGEN EZ RSV KIT | Becton, Dickinson & CO | 2002-12-10 |
| K021789 | QUICKLAB RSV | Integrated Biotechnology Corp. | 2002-11-20 |
| K021687 | BINAX NOW RSV TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN ACCESSORY PACK | Binax, Inc. | 2002-09-13 |
| K964870 | RSV ANTIGEN CONTROL SLIDES | Viral Antigens, Inc. | 1997-03-18 |
| K896097 | VIDAS RESPIRATORY SYNCYTIAL VIRUS (RSV) ASSAY | Vitek Systems, Inc. | 1990-02-26 |
| K884516 | FITC MURINE MONOCLONAL ANTI-RSV IGG | Whittaker Bioproducts, Inc. | 1989-01-13 |
| K882629 | DIRECTIGEN RESPIRATORY SYNCYTIAL VIRUS TEST KIT | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1988-10-31 |
| K882277 | ABBOTT TESTPACK(TM) RSV POSITIVE CONTROL | Abbott Laboratories | 1988-06-22 |
| K874127 | ABBOTT TESTPACK RSV | Abbott Laboratories | 1988-05-06 |
| K862743 | PATHFINDER(TM) RESPIRATORY SYNCYTIAL VIRUS | Kallestad Laboratories, Inc. | 1986-09-29 |
| K862429 | ABBOTT RSV EIA | Abbott Laboratories | 1986-09-16 |
| K854081 | IMAGEN RESPIRATORY SYNCYTIAL VIRUS TEST | Boots-Celltech Diagnostics, Inc. | 1986-01-03 |
| K853695 | RESPIRATORY SYNCYTIAL VIRUS ID REAGENT | Viromed Laboratories, Inc. | 1985-12-04 |
| K843673 | RESPIRATORY SYNCYTIAL VIRUS | Institute Virion , Ltd. | 1985-09-26 |
| K802936 | RESPIRATORY SYNCYTIAL VIRUS ANTIGEN & | Orion Diagnostica, Inc. | 1980-12-31 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 06950921308096 | CLUNGENE | Hangzhou Clongene Biotech Co., Ltd. | 2026-04-11 |
| 10742860100663 | OSOM RSV Test Home | SEKISUI DIAGNOSTICS, LLC | 2025-05-19 |
| 00742860100666 | OSOM RSV Test Home | SEKISUI DIAGNOSTICS, LLC | 2025-05-19 |
| 40612479277289 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2025-05-14 |
| 20612479277278 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2025-05-14 |
| 00810160810360 | Red Tunica | Rodimedi & Associates, Inc. | 2025-03-14 |
| 00810160810377 | Red Tunica | Rodimedi & Associates, Inc. | 2025-03-14 |
| 00612479269897 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2024-09-09 |
| 00612479269880 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2024-09-09 |
| 00895160002854 | Nano-Check RSV Test | NANO-DITECH CORPORATION | 2024-08-08 |
| 05032384502950 | IMAGEN Respiratory Syncytial Virus (RSV) | OXOID LIMITED | 2024-06-19 |
| 00722066008034 | Rapid Response | BTNX Inc | 2024-02-21 |
| 10722066008031 | Rapid Response | BTNX Inc | 2024-02-21 |
| 08033891327668 | CHORUS RESPIRATORY SYNCYTIAL VIRUS IgG | DIESSE DIAGNOSTICA SENESE SPA | 2024-01-22 |
| 10694644700036 | Easy Lab Pro RSV | AMERICAN BIO MEDICA CORPORATION | 2023-01-12 |
| 00840733101847 | TRU RSV | MERIDIAN BIOSCIENCE, INC. | 2020-12-09 |
| 00840733101977 | FLU/RSV Positive Control | MERIDIAN BIOSCIENCE, INC. | 2020-11-17 |
| 10811877011191 | BinaxNOW RSV | Alere Scarborough, Inc. | 2020-09-16 |
| 10811877011160 | BinaxNOW RSV | Alere Scarborough, Inc. | 2020-09-16 |
| 10811877011177 | BinaxNOW RSV | Alere Scarborough, Inc. | 2020-09-16 |
| 10811877011184 | BinaxNOW RSV | Alere Scarborough, Inc. | 2020-09-16 |
| 10811877010484 | BinaxNOW Nasopharyngeal Swab Accessory Kit | Alere Scarborough, Inc. | 2020-09-16 |
| 10811877011207 | BinaxNOW RSV Control Swab Kit | Alere Scarborough, Inc. | 2020-09-16 |
| 30014613202226 | QuickVue | QUIDEL CORPORATION | 2018-11-10 |
| 30014613202424 | Sofia | QUIDEL CORPORATION | 2018-11-10 |
| 30014613201939 | QuickVue | QUIDEL CORPORATION | 2018-11-10 |
| 10627966005206 | RAMP® RSV Control Swabs | Response Biomedical Corp | 2017-08-31 |
| 10627966005183 | RAMP® RSV TEST KIT; 25 TESTS | Response Biomedical Corp | 2017-08-31 |
| 10694644700029 | RDS | AMERICAN BIO MEDICA CORPORATION | 2016-09-23 |
| 10694644700012 | RDS | AMERICAN BIO MEDICA CORPORATION | 2016-09-23 |