LGC · Class II · 21 CFR 866.3305

FDA Product Code LGC: Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-specific

Leading manufacturers include Gull Laboratories, Inc., Baxter Diagnostics, Inc. and Ortho Diagnostic Systems, Inc..

38
Total
38
Cleared
168d
Avg days
1981
Since
38 devices
25–38 of 38
Cleared May 01, 1991
IMMUNODIAGNOSTIC ASSAY SYSTEM HERPES SIMPLEX VIRUS
K910499
Vitek Systems, Inc.
Microbiology · 85d
Cleared Sep 17, 1990
KODAK SURECELL HERPES (HSV) CONTROL FLUID SET
K903926
Eastman Kodak Company
Microbiology · 27d
Cleared Aug 09, 1990
SEROCARD HSV IGG ANTIBODY TEST KIT
K903070
Disease Detection International, Inc.
Microbiology · 28d
Cleared May 11, 1990
HERPTRAN CONCENTRATE
K900713
E.I. Dupont DE Nemours & Co., Inc.
Microbiology · 86d
Cleared Nov 17, 1989
IDEIA HERPES SIMPLEX VIRUS TEST
K871877
Boots-Celltech Diagnostics, Inc.
Microbiology · 918d
Cleared Apr 10, 1989
MODIFIED DDI SEROCARD HERPES IGG TEST KIT
K884246
Disease Detection International, Inc.
Microbiology · 181d
Cleared Feb 16, 1989
KODAK SURECELL HERPES (HSV) TEST KIT
K884680
Eastman Kodak Company
Microbiology · 99d
Cleared May 20, 1985
ABBOTT HSV EIA
K843622
Abbott Laboratories
Immunology · 248d
Cleared May 02, 1984
HSV ANTIGEN ELISA KIT
K834449
Ortho Diagnostic Systems, Inc.
Microbiology · 135d