Panels › Microbiology › Product code GQG · Class 1
Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus
Regulation 866.3480
1510(k)s in 12 months (32 all time)
0recalls in 12 months (3 all time)
3recalls that name a 510(k)
Top companies in GQG
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 30, 2026 | K253318 | Clungene RSV Antigen Rapid Test Hangzhou Clongene Biotech Co., Ltd., CN | GQG |
| Jul 30, 2024 | K240280 | Nano-Check RSV Test Nano-Ditech Corporation | GQG |
| Feb 22, 2017 | K162911 | Sofia RSV FIA on Sofia 2 analyzer Quidel Corporation | GQG |
| Nov 15, 2013 | K133140 | BD VERITOR SYSTEM FOR THE RAPID DETECTION OF RSV Becton, Dickinson & CO | GQG |
| Nov 7, 2013 | K132456 | BD VERITOR (TM) SYSTEM FOR RAPID DETECTION OF RSV Becton, Dickinson and Company | GQG |
| Aug 13, 2013 | K130398 | SOFIA(R) RSV FIA Quidel Corp. | GQG |
| Sep 18, 2012 | K121633 | BD VERITOR(TM) SYSTEM FOR THE RAPID DETECTION OF RSV Becton, Dickinson and Company | GQG |
| Sep 24, 2010 | K101918 | QUICKVUE RSV 10 Quidel Corp. | GQG |
| Jul 9, 2010 | K101514 | BD DIRECTIGEN EZ RSV Becton, Dickinson & CO | GQG |
| Jul 24, 2009 | K091235 | RAMP RSV ASSAY Response Biomedical Corp., CA | GQG |
| Apr 23, 2007 | K070747 | QUICK VUE RSV TEST, MODELS 20193, 20199 Quidel Corp. | GQG |
| Aug 13, 2004 | K041445 | IMMUNOCARD STAT! RSV MODEL #750630 Meridian Bioscience, Inc. | GQG |
| Oct 21, 2003 | K032166 | BINAX NOW RSV TEST, MODEL 430-000 AND BINAX NOW NASOPHARYNGEAL SWAB ACCESSORY PACK, MODEL 400-065 Binax, Inc. | GQG |
| Jan 29, 2003 | K022845 | SAS RSV TEST Sa Scientific, Inc. | GQG |
| Jan 14, 2003 | K023779 | RSV OIA Thermo Biostar, Inc. | GQG |
| Dec 10, 2002 | K022133 | BD DIRECTIGEN EZ RSV KIT Becton, Dickinson & CO | GQG |
| Nov 20, 2002 | K021789 | QUICKLAB RSV Integrated Biotechnology Corp. | GQG |
| Sep 13, 2002 | K021687 | BINAX NOW RSV TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN ACCESSORY PACK Binax, Inc. | GQG |
| Mar 18, 1997 | K964870 | RSV ANTIGEN CONTROL SLIDES Viral Antigens, Inc. | GQG |
| Feb 26, 1990 | K896097 | VIDAS RESPIRATORY SYNCYTIAL VIRUS (RSV) ASSAY Vitek Systems, Inc. | GQG |
| Jan 13, 1989 | K884516 | FITC MURINE MONOCLONAL ANTI-RSV IGG Whittaker Bioproducts, Inc. | GQG |
| Oct 31, 1988 | K882629 | DIRECTIGEN RESPIRATORY SYNCYTIAL VIRUS TEST KIT Bd Becton Dickinson Vacutainer Systems Preanalytic | GQG |
| Jun 22, 1988 | K882277 | ABBOTT TESTPACK(TM) RSV POSITIVE CONTROL Abbott Laboratories | GQG |
| May 6, 1988 | K874127 | ABBOTT TESTPACK RSV Abbott Laboratories | GQG |
| Sep 29, 1986 | K862743 | PATHFINDER(TM) RESPIRATORY SYNCYTIAL VIRUS Kallestad Laboratories, Inc. | GQG |
| Sep 16, 1986 | K862429 | ABBOTT RSV EIA Abbott Laboratories | GQG |
| Jan 3, 1986 | K854081 | IMAGEN RESPIRATORY SYNCYTIAL VIRUS TEST Boots-Celltech Diagnostics, Inc., GB | GQG |
| Dec 4, 1985 | K853695 | RESPIRATORY SYNCYTIAL VIRUS ID REAGENT Viromed Laboratories, Inc. | GQG |
| Sep 26, 1985 | K843673 | RESPIRATORY SYNCYTIAL VIRUS Institute Virion , Ltd. | GQG |
| Dec 31, 1980 | K802936 | RESPIRATORY SYNCYTIAL VIRUS ANTIGEN & Orion Diagnostica, Inc. | GQG |
| May 20, 1977 | K770808 | RESP. SYNCYTIAL-FA LABELLED PRESERUM Flow Laboratories, Inc. | GQG |
| May 20, 1977 | K770804 | RESP. SYNCYTIAL-FA LABELLHD (8-301-RF) Flow Laboratories, Inc. | GQG |
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