Atlas FDA

GQG

32 FDA 510(k) clearances · Product code

93 daysmedian time to decision
175 days90th percentile
32clearances measured

FDA profile

Official device name
Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus
Device class
Class I (low risk)
Regulation
21 CFR 866.3480
Medical specialty
Microbiology
Adverse events (MAUDE)
1997: 3 · 1999: 2
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Clungene RSV Antigen Rapid Test (K253318)Hangzhou Clongene Biotech Co., Ltd.2026-01-30
Nano-Check™ RSV Test (K240280)Nano-Ditech Corporation2024-07-30
Sofia RSV FIA on Sofia 2 analyzer (K162911)Quidel Corporation2017-02-22
BD VERITOR SYSTEM FOR THE RAPID DETECTION OF RSV (K133140)Becton, Dickinson & CO2013-11-15
BD VERITOR (TM) SYSTEM FOR RAPID DETECTION OF RSV (K132456)Becton, Dickinson and Company2013-11-07
SOFIA(R) RSV FIA (K130398)Quidel Corp.2013-08-13
BD VERITOR(TM) SYSTEM FOR THE RAPID DETECTION OF RSV (K121633)Becton, Dickinson and Company2012-09-18
QUICKVUE RSV 10 (K101918)Quidel Corp.2010-09-24
BD DIRECTIGEN EZ RSV (K101514)Becton, Dickinson & CO2010-07-09
RAMP RSV ASSAY (K091235)Response Biomedical Corp.2009-07-24
QUICK VUE RSV TEST, MODELS 20193, 20199 (K070747)Quidel Corp.2007-04-23
IMMUNOCARD STAT! RSV MODEL #750630 (K041445)Meridian Bioscience, Inc.2004-08-13
BINAX NOW RSV TEST, MODEL 430-000 AND BINAX NOW NASOPHARYNGEAL SWAB ACCESSORY PACK, MODEL 400-065 (K032166)Binax, Inc.2003-10-21
SAS RSV TEST (K022845)Sa Scientific, Inc.2003-01-29
RSV OIA (K023779)Thermo Biostar, Inc.2003-01-14
BD DIRECTIGEN EZ RSV KIT (K022133)Becton, Dickinson & CO2002-12-10
QUICKLAB RSV (K021789)Integrated Biotechnology Corp.2002-11-20
BINAX NOW RSV TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN ACCESSORY PACK (K021687)Binax, Inc.2002-09-13
RSV ANTIGEN CONTROL SLIDES (K964870)Viral Antigens, Inc.1997-03-18
VIDAS RESPIRATORY SYNCYTIAL VIRUS (RSV) ASSAY (K896097)Vitek Systems, Inc.1990-02-26
FITC MURINE MONOCLONAL ANTI-RSV IGG (K884516)Whittaker Bioproducts, Inc.1989-01-13
DIRECTIGEN RESPIRATORY SYNCYTIAL VIRUS TEST KIT (K882629)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-10-31
ABBOTT TESTPACK(TM) RSV POSITIVE CONTROL (K882277)Abbott Laboratories1988-06-22
ABBOTT TESTPACK RSV (K874127)Abbott Laboratories1988-05-06
PATHFINDER(TM) RESPIRATORY SYNCYTIAL VIRUS (K862743)Kallestad Laboratories, Inc.1986-09-29
ABBOTT RSV EIA (K862429)Abbott Laboratories1986-09-16
IMAGEN RESPIRATORY SYNCYTIAL VIRUS TEST (K854081)Boots-Celltech Diagnostics, Inc.1986-01-03
RESPIRATORY SYNCYTIAL VIRUS ID REAGENT (K853695)Viromed Laboratories, Inc.1985-12-04
RESPIRATORY SYNCYTIAL VIRUS (K843673)Institute Virion , Ltd.1985-09-26
RESPIRATORY SYNCYTIAL VIRUS ANTIGEN & (K802936)Orion Diagnostica, Inc.1980-12-31
RESP. SYNCYTIAL-FA LABELLED PRESERUM (K770808)Flow Laboratories, Inc.1977-05-20
RESP. SYNCYTIAL-FA LABELLHD (8-301-RF) (K770804)Flow Laboratories, Inc.1977-05-20

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Every clearance here is in the API, with alerts when new ones post.