LGC · Class II · 21 CFR 866.3305

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

Leading manufacturers include Diagnostic Products Corp., Eastman Kodak Company and Abbott Laboratories.

38
Total
38
Cleared
168d
Avg days
1981
Since

FDA 510(k) Cleared Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-specific Devices (Product Code LGC)

38 devices
1–24 of 38
Cleared Apr 18, 2001
MODIFICATION TO IMMULITE HERPES I & II IGG, MODEL L2KHS2 & L2KHS6
K010878
Diagnostic Products Corp.
Microbiology · 30d
Cleared Jun 21, 1996
IMMULITE HERPES I AND II IGG
K950670
Diagnostic Products Corp.
Microbiology · 494d
Cleared Sep 17, 1990
KODAK SURECELL HERPES (HSV) CONTROL FLUID SET
K903926
Eastman Kodak Company
Microbiology · 27d
Cleared May 11, 1990
HERPTRAN CONCENTRATE
K900713
E.I. Dupont DE Nemours & Co., Inc.
Microbiology · 86d
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

About Product Code LGC - Regulatory Context