LGCClass II

Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific

21 CFR 866.3305 / Microbiology

LGC is the FDA product code for Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific, a class II device type, regulated under 21 CFR 866.3305. As of 2026-09-10, FDA records hold 38 510(k) clearances under this code, the most recent dated 2003-11-26, and 7 recalls.

Classification record

Product code: LGC
Device name: Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific
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: 38
Ingested recalls: 7

Clearances, product code LGC

By decision year

38 clearances under product code LGC with a decision year between 1981 and 2003, 1992 the highest year at 8.

Show the numbers

510(k) clearances under FDA product code LGC by decision year
Year	Clearances
1981	1
1983	1
1984	1
1985	2
1989	3
1990	3
1991	5
1992	8
1996	2
1997	2
1998	1
1999	5
2000	2
2001	1
2003	1

Applicants with the most clearances

Product code LGC

Applicants holding the most 510(k) clearances under product code LGC
Applicant	Clearances
Gull Laboratories, Inc.	7
Baxter Diagnostics, Inc.	4
Ortho Diagnostic Systems, Inc.	3
Siemens Healthcare Diagnostics Inc.	2
Diamedix Corp.	2
Disease Detection International, Inc.	2
Eastman Kodak Company	2
Meridian Diagnostics, Inc.	2
Zeus Scientific LLC	2
Abbott Medical	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 18 companies shown, in name order