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

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 Nov 28, 2000
DIAMEDIX IS-HSV 1&2 IGM TEST SYSTEM
K002262
Diamedix Corp.
Microbiology · 126d
Cleared Sep 03, 1999
THE APTUS (AUTOMATED) APPLICATION OF THE HSV 1/2 IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR
K992166
Zeus Scientific, Inc.
Microbiology · 70d
Cleared Jun 25, 1999
PREMIER TYPE SPECIFIC HSV-2 IGG ELISA TEST
K984346
Meridian Diagnostics, Inc.
Microbiology · 203d
Cleared Mar 18, 1999
HSV-1 AND/OR -2 IGM ELISA TEST SYSTEM
K983656
Zeus Scientific, Inc.
Microbiology · 150d
Cleared Feb 26, 1999
HSV 1+2 IGG ELISA TEST
K983541
Gull Laboratories, Inc.
Microbiology · 140d
Cleared Sep 29, 1998
DIAMEDIX IS-HSV 1 & 2 IGG TEST SYSTEM
K981306
Diamedix Corp.
Microbiology · 172d
Cleared Feb 04, 1997
HERPES GROUP IGG ELISA TEST SYSTEM
K963645
Armkel, LLC
Microbiology · 145d
Cleared Jun 21, 1996
IMMULITE HERPES I AND II IGG
K950670
Diagnostic Products Corp.
Microbiology · 494d
Cleared May 23, 1996
PREMIER HSV PLUS
K953839
Meridian Diagnostics, Inc.
Microbiology · 281d
Cleared Dec 28, 1992
ORTHO HSV ANTIGEN ELISA TEST, MODIFICATION
K925208
Ortho Diagnostic Systems, Inc.
Microbiology · 91d
Cleared Dec 15, 1992
BARTELS HERPES SIMPLEX VIRUS 2 IGM EIA
K922333
Baxter Diagnostics, Inc.
Microbiology · 216d
Cleared Dec 15, 1992
BARTELS HERPES SIMPLEX VIRUS 1 IGM EIA
K922334
Baxter Diagnostics, Inc.
Microbiology · 216d
Cleared Oct 05, 1992
HSV-1 IGM ELISA TEST -- MODIFICATION
K922758
Gull Laboratories, Inc.
Microbiology · 119d
Cleared Oct 05, 1992
HSV-2 IGM ELISA TEST--MODIFICATION
K922759
Gull Laboratories, Inc.
Microbiology · 119d
Cleared Sep 28, 1992
BARTELS HERPES SIMPLEX VIRUS 2 IGG EIA
K922583
Baxter Diagnostics, Inc.
Microbiology · 124d
Cleared Sep 18, 1992
BARTELS HERPES SIMPLEX VIRUS 1 IGG EIA
K922584
Baxter Diagnostics, Inc.
Microbiology · 114d
Cleared Apr 22, 1992
ORTHO HSV ANTIGEN ELISA TEST
K915551
Ortho Diagnostic Systems, Inc.
Microbiology · 133d
Cleared May 28, 1991
HSV-2 IGG ELISA TEST
K910952
Gull Laboratories, Inc.
Microbiology · 82d
Cleared May 28, 1991
HSV-2 IGM ELISA TEST
K910953
Gull Laboratories, Inc.
Microbiology · 82d
Cleared May 28, 1991
HSV-1 IGG ELISA TEST
K910954
Gull Laboratories, Inc.
Microbiology · 83d
Cleared May 28, 1991
HSV-1 IGM ELISA TEST
K910955
Gull Laboratories, Inc.
Microbiology · 83d
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

About Product Code LGC - Regulatory Context