GQNClass II

Antigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2

21 CFR 866.3305 / Microbiology

GQN is the FDA product code for Antigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2, a class II device type, regulated under 21 CFR 866.3305. As of 2026-09-10, FDA records hold 34 510(k) clearances under this code, the most recent dated 2007-10-24, and no recalls.

Classification record

Product code: GQN
Device name: Antigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2
Regulation: 21 CFR 866.3305
Device class: Class II
Review panel: Microbiology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 34
Ingested recalls: 0

Clearances, product code GQN

By decision year

34 clearances under product code GQN with a decision year between 1979 and 2007, 1988 the highest year at 10.

Show the numbers

510(k) clearances under FDA product code GQN by decision year
Year	Clearances
1979	1
1980	1
1981	1
1983	1
1984	2
1985	5
1986	2
1987	2
1988	10
1991	1
1995	1
1996	1
1997	3
1999	1
2007	2

Applicants with the most clearances

Product code GQN

Applicants holding the most 510(k) clearances under product code GQN
Applicant	Clearances
Ortho-Clinical Diagnostics, Inc.	7
Cordis US Corp.	2
Enzo Biochem, Inc.	2
Litton Bionetics	2
Viral Antigens, Inc.	2
Whittaker Bioproducts, Inc.	2
Bartels Immunodiagnostic Supplies, Inc.	1
Boots-Celltech Diagnostics, Inc.	1
Difco Laboratories, Inc.	1
E.I. Dupont de Nemours & Co., Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code