GQG · Class I · 21 CFR 866.3480

FDA Product Code GQG: Antigen, Cf (including Cf Controls), Respiratory Syncytial Virus

Leading manufacturers include Quidel Corp., Abbott Laboratories and Becton, Dickinson & CO.

32
Total
32
Cleared
105d
Avg days
1977
Since
Stable submission activity - 1 submissions in the last 2 years
Review times increasing: avg 122d recently vs 104d historically

FDA 510(k) Cleared Antigen, Cf (including Cf Controls), Respiratory Syncytial Virus Devices (Product Code GQG)

32 devices
1–24 of 32
Cleared Jan 30, 2026
Clungene RSV Antigen Rapid Test
K253318
Hangzhou Clongene Biotech Co., Ltd.
Microbiology · 122d
Cleared Jul 30, 2024
Nano-Check™ RSV Test
K240280
Nano-Ditech Corporation
Microbiology · 180d
Cleared Feb 22, 2017
Sofia RSV FIA on Sofia 2 analyzer
K162911
Quidel Corporation
Microbiology · 128d
Cleared Nov 15, 2013
BD VERITOR SYSTEM FOR THE RAPID DETECTION OF RSV
K133140
Becton, Dickinson & CO
Microbiology · 29d
Cleared Nov 07, 2013
BD VERITOR (TM) SYSTEM FOR RAPID DETECTION OF RSV
K132456
Becton, Dickinson and Company
Microbiology · 93d
Cleared Aug 13, 2013
SOFIA(R) RSV FIA
K130398
Quidel Corp.
Microbiology · 175d
Cleared Sep 18, 2012
BD VERITOR(TM) SYSTEM FOR THE RAPID DETECTION OF RSV
K121633
Becton, Dickinson and Company
Microbiology · 106d
Cleared Sep 24, 2010
QUICKVUE RSV 10
K101918
Quidel Corp.
Microbiology · 77d
Cleared Jul 09, 2010
BD DIRECTIGEN EZ RSV
K101514
Becton, Dickinson & CO
Microbiology · 37d
Cleared Apr 23, 2007
QUICK VUE RSV TEST, MODELS 20193, 20199
K070747
Quidel Corp.
Microbiology · 35d
Cleared Aug 13, 2004
IMMUNOCARD STAT! RSV MODEL #750630
K041445
Meridian Bioscience, Inc.
Microbiology · 73d
Cleared Oct 21, 2003
BINAX NOW RSV TEST, MODEL 430-000 AND BINAX NOW NASOPHARYNGEAL SWAB ACCESSORY PACK, MODEL 400-065
K032166
Binax, Inc.
Microbiology · 97d
Cleared Jan 29, 2003
SAS RSV TEST
K022845
Sa Scientific, Inc.
Microbiology · 155d
Cleared Dec 10, 2002
BD DIRECTIGEN EZ RSV KIT
K022133
Becton, Dickinson & CO
Microbiology · 162d
Cleared Sep 13, 2002
BINAX NOW RSV TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN ACCESSORY PACK
K021687
Binax, Inc.
Microbiology · 114d
Cleared Feb 26, 1990
VIDAS RESPIRATORY SYNCYTIAL VIRUS (RSV) ASSAY
K896097
Vitek Systems, Inc.
Microbiology · 129d
Cleared Jan 13, 1989
FITC MURINE MONOCLONAL ANTI-RSV IGG
K884516
Whittaker Bioproducts, Inc.
Microbiology · 78d
Cleared Oct 31, 1988
DIRECTIGEN RESPIRATORY SYNCYTIAL VIRUS TEST KIT
K882629
Bd Becton Dickinson Vacutainer Systems Preanalytic
Microbiology · 126d
Cleared Jun 22, 1988
ABBOTT TESTPACK(TM) RSV POSITIVE CONTROL
K882277
Abbott Laboratories
Microbiology · 22d
Cleared May 06, 1988
ABBOTT TESTPACK RSV
K874127
Abbott Laboratories
Microbiology · 206d
Cleared Sep 29, 1986
PATHFINDER(TM) RESPIRATORY SYNCYTIAL VIRUS
K862743
Kallestad Laboratories, Inc.
Microbiology · 70d
Cleared Sep 16, 1986
ABBOTT RSV EIA
K862429
Abbott Laboratories
Microbiology · 82d
Cleared Dec 04, 1985
RESPIRATORY SYNCYTIAL VIRUS ID REAGENT
K853695
Viromed Laboratories, Inc.
Microbiology · 91d
Cleared Dec 31, 1980
RESPIRATORY SYNCYTIAL VIRUS ANTIGEN &
K802936
Orion Diagnostica, Inc.
Microbiology · 42d

About Product Code GQG - Regulatory Context

510(k) Submission Activity

32 total 510(k) submissions under product code GQG since 1977, with 32 receiving FDA clearance (average review time: 105 days).

Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.

FDA 510(k) Review Time - GQG Product Code

Recent submissions under GQG have taken an average of 122 days to reach a decision - up from 104 days historically. Manufacturers should account for longer review timelines in current project planning.

GQG devices are reviewed by the Microbiology panel. Browse all Microbiology devices →