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Panels › Microbiology › Product code LGC · Class 2

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

Regulation 866.3305

0510(k)s in 12 months (38 all time)
0recalls in 12 months (7 all time)
5recalls that name a 510(k)
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Top companies in LGC

Decided510(k)Device and applicantCode
Nov 26, 2003K033059HERPES GROUP IGG
Trinity Biotech, Inc.
LGC
Apr 18, 2001K010878MODIFICATION TO IMMULITE HERPES I & II IGG, MODEL L2KHS2 & L2KHS6
Diagnostic Products Corp.
LGC
Nov 28, 2000K002262DIAMEDIX IS-HSV 1&2 IGM TEST SYSTEM
Diamedix Corp.
LGC
Apr 14, 2000K000238HSV-1 & HSV-2 DIFFERENTIATION IMMUNOBLOT IGG, MODEL IB0900G
Mrl Diagnostics
LGC
Sep 3, 1999K992166THE APTUS (AUTOMATED) APPLICATION OF THE HSV 1/2 IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR
Zeus Scientific, Inc.
LGC
Aug 19, 1999K983886POCKIT HSV 2 RAPID TEST
Diagnology , Ltd.
LGC
Jun 25, 1999K984346PREMIER TYPE SPECIFIC HSV-2 IGG ELISA TEST
Meridian Diagnostics, Inc.
LGC
Mar 18, 1999K983656HSV-1 AND/OR -2 IGM ELISA TEST SYSTEM
Zeus Scientific, Inc.
LGC
Feb 26, 1999K983541HSV 1+2 IGG ELISA TEST
Gull Laboratories, Inc.
LGC
Sep 29, 1998K981306DIAMEDIX IS-HSV 1 & 2 IGG TEST SYSTEM
Diamedix Corp.
LGC
Feb 4, 1997K963645HERPES GROUP IGG ELISA TEST SYSTEM
Armkel, LLC
LGC
Jan 22, 1997K963282SERAQUEST HSV IGG
Quest Intl., Inc.
LGC
Jun 21, 1996K950670IMMULITE HERPES I AND II IGG
Diagnostic Products Corp.
LGC
May 23, 1996K953839PREMIER HSV PLUS
Meridian Diagnostics, Inc.
LGC
Dec 28, 1992K925208ORTHO HSV ANTIGEN ELISA TEST, MODIFICATION
Ortho Diagnostic Systems, Inc.
LGC
Dec 15, 1992K922334BARTELS HERPES SIMPLEX VIRUS 1 IGM EIA
Baxter Diagnostics, Inc.
LGC
Dec 15, 1992K922333BARTELS HERPES SIMPLEX VIRUS 2 IGM EIA
Baxter Diagnostics, Inc.
LGC
Oct 5, 1992K922759HSV-2 IGM ELISA TEST--MODIFICATION
Gull Laboratories, Inc.
LGC
Oct 5, 1992K922758HSV-1 IGM ELISA TEST -- MODIFICATION
Gull Laboratories, Inc.
LGC
Sep 28, 1992K922583BARTELS HERPES SIMPLEX VIRUS 2 IGG EIA
Baxter Diagnostics, Inc.
LGC
Sep 18, 1992K922584BARTELS HERPES SIMPLEX VIRUS 1 IGG EIA
Baxter Diagnostics, Inc.
LGC
Apr 22, 1992K915551ORTHO HSV ANTIGEN ELISA TEST
Ortho Diagnostic Systems, Inc.
LGC
May 28, 1991K910955HSV-1 IGM ELISA TEST
Gull Laboratories, Inc.
LGC
May 28, 1991K910954HSV-1 IGG ELISA TEST
Gull Laboratories, Inc.
LGC
May 28, 1991K910953HSV-2 IGM ELISA TEST
Gull Laboratories, Inc.
LGC
May 28, 1991K910952HSV-2 IGG ELISA TEST
Gull Laboratories, Inc.
LGC
May 1, 1991K910499IMMUNODIAGNOSTIC ASSAY SYSTEM HERPES SIMPLEX VIRUS
Vitek Systems, Inc.
LGC
Sep 17, 1990K903926KODAK SURECELL HERPES (HSV) CONTROL FLUID SET
Eastman Kodak Company
LGC
Aug 9, 1990K903070SEROCARD HSV IGG ANTIBODY TEST KIT
Disease Detection International, Inc.
LGC
May 11, 1990K900713HERPTRAN CONCENTRATE
E.I. Dupont DE Nemours & Co., Inc.
LGC
Nov 17, 1989K871877IDEIA HERPES SIMPLEX VIRUS TEST
Boots-Celltech Diagnostics, Inc., GB
LGC
Apr 10, 1989K884246MODIFIED DDI SEROCARD HERPES IGG TEST KIT
Disease Detection International, Inc.
LGC
Feb 16, 1989K884680KODAK SURECELL HERPES (HSV) TEST KIT
Eastman Kodak Company
LGC
Jun 21, 1985K843077ELISA FOR HERPES SIMPLEX VIRUS
Scientific Research
LGC
May 20, 1985K843622ABBOTT HSV EIA
Abbott Laboratories
LGC
May 2, 1984K834449HSV ANTIGEN ELISA KIT
Ortho Diagnostic Systems, Inc.
LGC
Jul 26, 1983K822883HERPELISA KIT
M.A. Bioproducts
LGC
Feb 9, 1981K802526TEST KIT FOR DETECTION OF HERPES SIMPLEX
Bartels & Stout, Inc.
LGC

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