FDA Product Code
FDA Product Code GQG — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Microbiology
- 21 CFR Citation
- 866.3480
510(k) Clearances — 32 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K253318 | Clungene RSV Antigen Rapid Test | Hangzhou Clongene Biotech Co., Ltd. | 2026-01-30 | Traditional | PDF ↗ |
| K240280 | Nano-Check RSV Test | Nano-Ditech Corporation | 2024-07-30 | Dual Track | PDF ↗ |
| K162911 | Sofia RSV FIA on Sofia 2 analyzer | Quidel Corporation | 2017-02-22 | Traditional | PDF ↗ |
| K133140 | BD VERITOR SYSTEM FOR THE RAPID DETECTION OF RSV | Becton, Dickinson & CO | 2013-11-15 | Special | PDF ↗ |
| K132456 | BD VERITOR (TM) SYSTEM FOR RAPID DETECTION OF RSV | Becton, Dickinson and Company | 2013-11-07 | Traditional | PDF ↗ |
| K130398 | SOFIA(R) RSV FIA | Quidel Corp. | 2013-08-13 | Traditional | PDF ↗ |
| K121633 | BD VERITOR(TM) SYSTEM FOR THE RAPID DETECTION OF RSV | Becton, Dickinson and Company | 2012-09-18 | Traditional | PDF ↗ |
| K101918 | QUICKVUE RSV 10 | Quidel Corp. | 2010-09-24 | Traditional | PDF ↗ |
| K101514 | BD DIRECTIGEN EZ RSV | Becton, Dickinson & CO | 2010-07-09 | Traditional | PDF ↗ |
| K091235 | RAMP RSV ASSAY | Response Biomedical Corp. | 2009-07-24 | Traditional | PDF ↗ |
| K070747 | QUICK VUE RSV TEST, MODELS 20193, 20199 | Quidel Corp. | 2007-04-23 | Traditional | PDF ↗ |
| K041445 | IMMUNOCARD STAT! RSV MODEL #750630 | Meridian Bioscience, Inc. | 2004-08-13 | Traditional | PDF ↗ |
| K032166 | BINAX NOW RSV TEST, MODEL 430-000 AND BINAX NOW NASOPHARYNGEAL SWAB ACCESSORY PACK, MODEL 400-065 | Binax, Inc. | 2003-10-21 | Traditional | PDF ↗ |
| K022845 | SAS RSV TEST | Sa Scientific, Inc. | 2003-01-29 | Traditional | PDF ↗ |
| K023779 | RSV OIA | Thermo Biostar, Inc. | 2003-01-14 | Traditional | PDF ↗ |
| K022133 | BD DIRECTIGEN EZ RSV KIT | Becton, Dickinson & CO | 2002-12-10 | Traditional | PDF ↗ |
| K021789 | QUICKLAB RSV | Integrated Biotechnology Corp. | 2002-11-20 | Traditional | PDF ↗ |
| K021687 | BINAX NOW RSV TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN ACCESSORY PACK | Binax, Inc. | 2002-09-13 | Traditional | PDF ↗ |
| K964870 | RSV ANTIGEN CONTROL SLIDES | Viral Antigens, Inc. | 1997-03-18 | Traditional | PDF ↗ |
| K896097 | VIDAS RESPIRATORY SYNCYTIAL VIRUS (RSV) ASSAY | Vitek Systems, Inc. | 1990-02-26 | Traditional | PDF ↗ |
| K884516 | FITC MURINE MONOCLONAL ANTI-RSV IGG | Whittaker Bioproducts, Inc. | 1989-01-13 | Traditional | PDF ↗ |
| K882629 | DIRECTIGEN RESPIRATORY SYNCYTIAL VIRUS TEST KIT | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1988-10-31 | Traditional | PDF ↗ |
| K882277 | ABBOTT TESTPACK(TM) RSV POSITIVE CONTROL | Abbott Laboratories | 1988-06-22 | Traditional | PDF ↗ |
| K874127 | ABBOTT TESTPACK RSV | Abbott Laboratories | 1988-05-06 | Traditional | PDF ↗ |
| K862743 | PATHFINDER(TM) RESPIRATORY SYNCYTIAL VIRUS | Kallestad Laboratories, Inc. | 1986-09-29 | Traditional | PDF ↗ |
| K862429 | ABBOTT RSV EIA | Abbott Laboratories | 1986-09-16 | Traditional | PDF ↗ |
| K854081 | IMAGEN RESPIRATORY SYNCYTIAL VIRUS TEST | Boots-Celltech Diagnostics, Inc. | 1986-01-03 | Traditional | PDF ↗ |
| K853695 | RESPIRATORY SYNCYTIAL VIRUS ID REAGENT | Viromed Laboratories, Inc. | 1985-12-04 | Traditional | PDF ↗ |
| K843673 | RESPIRATORY SYNCYTIAL VIRUS | Institute Virion , Ltd. | 1985-09-26 | Traditional | PDF ↗ |
| K802936 | RESPIRATORY SYNCYTIAL VIRUS ANTIGEN & | Orion Diagnostica, Inc. | 1980-12-31 | Traditional | PDF ↗ |
| K770804 | RESP. SYNCYTIAL-FA LABELLHD (8-301-RF) | Flow Laboratories, Inc. | 1977-05-20 | Traditional | PDF ↗ |
| K770808 | RESP. SYNCYTIAL-FA LABELLED PRESERUM | Flow Laboratories, Inc. | 1977-05-20 | Traditional | PDF ↗ |
Product code GQG · Class I · Microbiology. Data: openFDA.