GQGClass I

Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus

21 CFR 866.3480 / Microbiology

GQG is the FDA product code for Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus, a class I device type, regulated under 21 CFR 866.3480. As of 2026-09-10, FDA records hold 32 510(k) clearances under this code, the most recent dated 2026-01-30, and 3 recalls.

Classification record

Product code: GQG
Device name: Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus
Regulation: 21 CFR 866.3480
Device class: Class I
Review panel: Microbiology
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 32
Ingested recalls: 3

Clearances, product code GQG

By decision year

32 clearances under product code GQG with a decision year between 1977 and 2026, 1986 the highest year at 3.

Show the numbers

510(k) clearances under FDA product code GQG by decision year
Year	Clearances
1977	2
1980	1
1985	2
1986	3
1988	3
1989	1
1990	1
1997	1
2002	3
2003	3
2004	1
2007	1
2009	1
2010	2
2012	1
2013	3
2017	1
2024	1
2026	1

Applicants with the most clearances

Product code GQG

Applicants holding the most 510(k) clearances under product code GQG
Applicant	Clearances
Becton Dickinson & Co	5
Ortho-Clinical Diagnostics, Inc.	4
Abbott Medical	3
Binax, Inc.	2
Flow Laboratories, Inc.	2
BD Becton Dickinson Vacutainer Systems Preanalytic	1
Boots-Celltech Diagnostics, Inc.	1
Hangzhou Clongene Biotech Co., Ltd.	1
Institute Virion, Ltd.	1
Integrated Biotechnology Corp.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 31 companies shown, in name order