Product code GQG— Microbiology
ABBOTT RSV EIA
- Classification name
- Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus
- Device class
- Class 1
- Regulation
- 21 CFR 866.3480
- Advisory panel
- Microbiology
- Total cleared
- 32
- First cleared
- Most recent
Market context for product code GQG
FDA has cleared devices under product code GQG between 1977 and 2026, filed by 23 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Clearances per year
last 15 years- 2026
- 2024
- 2017
- 2013
- 2012
- 2010
- 2009
- 2007
- 2004
- 2003
- 2002
- 1997
- 1990
- 1989
- 1988
Top applicants under product code GQG
Recent clearances under product code GQG
- K253318 — Clungene RSV Antigen Rapid Test
- K240280 — Nano-Check RSV Test
- K162911 — Sofia RSV FIA on Sofia 2 analyzer
- K133140 — BD VERITOR SYSTEM FOR THE RAPID DETECTION OF RSV
- K132456 — BD VERITOR (TM) SYSTEM FOR RAPID DETECTION OF RSV
- K130398 — SOFIA(R) RSV FIA
- K121633 — BD VERITOR(TM) SYSTEM FOR THE RAPID DETECTION OF RSV
- K101918 — QUICKVUE RSV 10
- K101514 — BD DIRECTIGEN EZ RSV
- K091235 — RAMP RSV ASSAY
- K070747 — QUICK VUE RSV TEST, MODELS 20193, 20199
- K041445 — IMMUNOCARD STAT! RSV MODEL #750630
- K032166 — BINAX NOW RSV TEST, MODEL 430-000 AND BINAX NOW NASOPHARYNGEAL SWAB ACCESSORY PACK, MODEL 400-065
- K022845 — SAS RSV TEST
- K023779 — RSV OIA
- K022133 — BD DIRECTIGEN EZ RSV KIT
- K021789 — QUICKLAB RSV
- K021687 — BINAX NOW RSV TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN ACCESSORY PACK
- K964870 — RSV ANTIGEN CONTROL SLIDES
- K896097 — VIDAS RESPIRATORY SYNCYTIAL VIRUS (RSV) ASSAY
- K884516 — FITC MURINE MONOCLONAL ANTI-RSV IGG
- K882629 — DIRECTIGEN RESPIRATORY SYNCYTIAL VIRUS TEST KIT
- K882277 — ABBOTT TESTPACK(TM) RSV POSITIVE CONTROL
- K874127 — ABBOTT TESTPACK RSV
- K862743 — PATHFINDER(TM) RESPIRATORY SYNCYTIAL VIRUS
- K862429 — ABBOTT RSV EIA
- K854081 — IMAGEN RESPIRATORY SYNCYTIAL VIRUS TEST
- K853695 — RESPIRATORY SYNCYTIAL VIRUS ID REAGENT
- K843673 — RESPIRATORY SYNCYTIAL VIRUS
- K802936 — RESPIRATORY SYNCYTIAL VIRUS ANTIGEN &
- K770804 — RESP. SYNCYTIAL-FA LABELLHD (8-301-RF)
- K770808 — RESP. SYNCYTIAL-FA LABELLED PRESERUM
Data sourced from openFDA. This site is unofficial and independent of the FDA.