Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

GQN — Predicate Candidate Screening

34 FDA 510(k) clearances under this product code; the 50 most recent screened below.

138 daysmedian FDA review time

359 days90th percentile

34clearances measured

K-number	Device	Applicant	Decided	Review days
K070265	DIAGNOSTIC HYBRIDS' D3 DFA HERPES SIMPLEX VIRUS IDENTIFICATI	Diagnostic Hybrids, Inc.	2007-10-24	268
K063798	DIAGNOSTIC HYBRIDS' D3 DFA HERPES SIMPLEX VIRUS IDENTIFICATI	Diagnostic Hybrids, Inc.	2007-09-21	273
K991880	LIGHT DIAGNOSTICS SIMULFLUOR HSV 1/2 IMMUNOFLUORECENCE ASSAY	Light Diagnostics	1999-11-09	160
K971662	ELVIS HSV ID/TYPING TEST SYSTEM	Diagnostic Hybrids, Inc.	1997-11-18	203
K964874	HSV-1 ANTIGEN CONTROL SLIDES	Viral Antigens, Inc.	1997-07-01	208
K971101	HSV-2 ANTIGEN CONTROL SLIDES	Viral Antigens, Inc.	1997-07-01	97
K960578	ELVIS HSV GOLD	Diagnostic Hybrids, Inc.	1996-09-05	206
K941924	ELVIS HSV	Diagnostic Hybrids, Inc.	1995-05-01	376
K911345	HSV IN SITU DNA PROBE HYBRIDIZATION TEST KIT	Diagnostic Hybrids, Inc.	1991-06-17	82
K884761	MODIFIED CELL-MATICS HERPES SIMPLEX VIRUS DETECT.	Difco Laboratories, Inc.	1988-12-05	21
K883684	HERPES VIRUS CONTROL SLIDES	Val Tech Diagnostics, Inc.	1988-09-28	30
K873529	HYBRIWICK SYSTEM: HERPES DNA PROBE TEST KIT	Diagnostic Hybrids, Inc.	1988-08-25	359
K875311	WELLCOZYME HSV WZO2	Wellcome Diagnostics	1988-08-03	218
K880604	COLORGENE HSV DNA HYBRIDIZATION TEST	Enzo Biochem, Inc.	1988-08-03	173
K881180	FITC MURINE MONOCLONAL ANTI-HERPES TYPE 1 IGG	Whittaker Bioproducts, Inc.	1988-05-13	66
K880996	FITC MURINE MONOCLONAL ANTI-HSV BIVALENT IGG	Whittaker Bioproducts, Inc.	1988-05-13	66
K872632	DU PONT HERPCHEK HSV ANTIGEN ELISA TEST KIT	E.I. Dupont DE Nemours & Co., Inc.	1988-02-18	227
K880436	MICROTRAK HSV CULTURE IDENTIFICATION TEST	Syva Co.	1988-02-18	16
K874863	RAMP HERPES SIMPLEX VIRUS (HSV) (CCT)	Monoclonal Antibodies, Inc.	1988-02-16	83
K870733	COLORGENE DNA HYBRIDIZATION TEST FOR HSV CONFIRMA.	Enzo Biochem, Inc.	1987-05-26	90
K870602	IMAGEN HERPES SIMPLEX VIRUS (HSV) TYPING TEST	Boots-Celltech Diagnostics, Inc.	1987-05-08	86
K854974	HSV IDR	Genus Diagnostics	1986-03-07	85
K854488	ORTHO HSV ANTIGEN ELISA TEST	Ortho Diagnostic Systems, Inc.	1986-02-04	88
K853307	DIRECT ELISA FOR HERPES SIMPLEX VIRUS	Fairleigh Dickinson Laboratories, Inc.	1985-12-23	138
K842830	IMMUNOPER-OXIDASE TEST KIT FOR DETECT OF	Bartels Immunodiagnostic Supplies, Inc.	1985-11-26	494
K843658	H. SIMPLEX VIRUS	Institute Virion , Ltd.	1985-09-26	374
K850609	HERPES SIMPLEX GROUP CF ANTIGEN	Hillcrest Biologicals	1985-05-09	83
K843751	CORDIA HS ANTIBODY TYPING REAGENTS	Cordis Corp.	1985-04-24	211
K841191	MICROTRAKSPECIMAN ID TYPING TEST CONTR	Syva Co.	1984-06-19	90
K832541	SIMPLEX-2	Gentech Australia	1984-02-04	190
K832875	CORDIA HS	Cordis Corp.	1983-11-28	94
K811021	HERPES	Immuno-Diagnostic Products, Inc.	1981-11-05	204
K801721	HSV BIO-BEAD TITRATION KIT	Litton Bionetics	1980-09-16	55
K791614	HSV BIO-BEAD SCREEN KIT	Litton Bionetics	1979-11-13	84

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda