GQG · Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus
Microbiology · 21 CFR 866.3480 · Class 1
Overview
| Product Code | GQG |
|---|---|
| Device Name | Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus |
| Regulation | 21 CFR 866.3480 |
| Device Class | Class 1 |
| Review Panel | Microbiology |
Identification
Respiratory syncytial virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to respiratory syncytial virus in serum. Additionally, some of these reagents consist of respiratory syncytial virus antisera conjugated with a fluorescent dye (immunofluorescent reagents) and used to identify respiratory syncytial viruses from clinical specimens or from tissue culture isolates derived from clinical specimens. The identification aids in the diagnosis of respiratory syncytial virus infections and provides epidemiological information on diseases caused by these viruses. Respiratory syncytial viruses cause a number of respiratory tract infections, including the common cold, pharyngitis, and infantile bronchopneumonia.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.
Recent Cleared Devices (20 of 32)
Showing 20 most recent of 32 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K253318 | Clungene RSV Antigen Rapid Test | Hangzhou Clongene Biotech Co., Ltd. | Jan 30, 2026 | SESE |
| K240280 | Nano-Check RSV Test | Nano-Ditech Corporation | Jul 30, 2024 | SESE |
| K162911 | Sofia RSV FIA on Sofia 2 analyzer | Quidel Corporation | Feb 22, 2017 | SESE |
| K133140 | BD VERITOR SYSTEM FOR THE RAPID DETECTION OF RSV | Becton, Dickinson & CO | Nov 15, 2013 | SESE |
| K132456 | BD VERITOR (TM) SYSTEM FOR RAPID DETECTION OF RSV | Becton, Dickinson and Company | Nov 7, 2013 | SESE |
| K130398 | SOFIA(R) RSV FIA | Quidel Corp. | Aug 13, 2013 | SESE |
| K121633 | BD VERITOR(TM) SYSTEM FOR THE RAPID DETECTION OF RSV | Becton, Dickinson and Company | Sep 18, 2012 | SESE |
| K101918 | QUICKVUE RSV 10 | Quidel Corp. | Sep 24, 2010 | SESE |
| K101514 | BD DIRECTIGEN EZ RSV | Becton, Dickinson & CO | Jul 9, 2010 | SESE |
| K091235 | RAMP RSV ASSAY | Response Biomedical Corp. | Jul 24, 2009 | SESE |
| K070747 | QUICK VUE RSV TEST, MODELS 20193, 20199 | Quidel Corp. | Apr 23, 2007 | SESE |
| K041445 | IMMUNOCARD STAT! RSV MODEL #750630 | Meridian Bioscience, Inc. | Aug 13, 2004 | SESE |
| K032166 | BINAX NOW RSV TEST, MODEL 430-000 AND BINAX NOW NASOPHARYNGEAL SWAB ACCESSORY PACK, MODEL 400-065 | Binax, Inc. | Oct 21, 2003 | SESE |
| K022845 | SAS RSV TEST | Sa Scientific, Inc. | Jan 29, 2003 | SESE |
| K023779 | RSV OIA | Thermo Biostar, Inc. | Jan 14, 2003 | SESE |
| K022133 | BD DIRECTIGEN EZ RSV KIT | Becton, Dickinson & CO | Dec 10, 2002 | SESE |
| K021789 | QUICKLAB RSV | Integrated Biotechnology Corp. | Nov 20, 2002 | SESE |
| K021687 | BINAX NOW RSV TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN ACCESSORY PACK | Binax, Inc. | Sep 13, 2002 | SESE |
| K964870 | RSV ANTIGEN CONTROL SLIDES | Viral Antigens, Inc. | Mar 18, 1997 | SESE |
| K896097 | VIDAS RESPIRATORY SYNCYTIAL VIRUS (RSV) ASSAY | Vitek Systems, Inc. | Feb 26, 1990 | SESE |
Top Applicants
- Abbott Laboratories — 3 clearances
- Becton, Dickinson & CO — 3 clearances
- Quidel Corp. — 3 clearances
- Becton, Dickinson and Company — 2 clearances
- Binax, Inc. — 2 clearances
