Atlas FDA

LGC

38 FDA 510(k) clearances · Product code

126 daysmedian time to decision
306 days90th percentile
38clearances measured

FDA profile

Official device name
Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific
Device class
Class II (moderate risk)
Regulation
21 CFR 866.3305
Medical specialty
Microbiology
Adverse events (MAUDE)
2007: 4
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
HERPES GROUP IGG (K033059)Trinity Biotech, Inc.2003-11-26
MODIFICATION TO IMMULITE HERPES I & II IGG, MODEL L2KHS2 & L2KHS6 (K010878)Diagnostic Products Corp.2001-04-18
DIAMEDIX IS-HSV 1&2 IGM TEST SYSTEM (K002262)Diamedix Corp.2000-11-28
HSV-1 & HSV-2 DIFFERENTIATION IMMUNOBLOT IGG, MODEL IB0900G (K000238)Mrl Diagnostics2000-04-14
THE APTUS (AUTOMATED) APPLICATION OF THE HSV 1/2 IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR (K992166)Zeus Scientific, Inc.1999-09-03
POCKIT HSV 2 RAPID TEST (K983886)Diagnology , Ltd.1999-08-19
PREMIER TYPE SPECIFIC HSV-2 IGG ELISA TEST (K984346)Meridian Diagnostics, Inc.1999-06-25
HSV-1 AND/OR -2 IGM ELISA TEST SYSTEM (K983656)Zeus Scientific, Inc.1999-03-18
HSV 1+2 IGG ELISA TEST (K983541)Gull Laboratories, Inc.1999-02-26
DIAMEDIX IS-HSV 1 & 2 IGG TEST SYSTEM (K981306)Diamedix Corp.1998-09-29
HERPES GROUP IGG ELISA TEST SYSTEM (K963645)Armkel, LLC1997-02-04
SERAQUEST HSV IGG (K963282)Quest Intl., Inc.1997-01-22
IMMULITE HERPES I AND II IGG (K950670)Diagnostic Products Corp.1996-06-21
PREMIER HSV PLUS (K953839)Meridian Diagnostics, Inc.1996-05-23
ORTHO HSV ANTIGEN ELISA TEST, MODIFICATION (K925208)Ortho Diagnostic Systems, Inc.1992-12-28
BARTELS HERPES SIMPLEX VIRUS 1 IGM EIA (K922334)Baxter Diagnostics, Inc.1992-12-15
BARTELS HERPES SIMPLEX VIRUS 2 IGM EIA (K922333)Baxter Diagnostics, Inc.1992-12-15
HSV-2 IGM ELISA TEST--MODIFICATION (K922759)Gull Laboratories, Inc.1992-10-05
HSV-1 IGM ELISA TEST -- MODIFICATION (K922758)Gull Laboratories, Inc.1992-10-05
BARTELS HERPES SIMPLEX VIRUS 2 IGG EIA (K922583)Baxter Diagnostics, Inc.1992-09-28
BARTELS HERPES SIMPLEX VIRUS 1 IGG EIA (K922584)Baxter Diagnostics, Inc.1992-09-18
ORTHO HSV ANTIGEN ELISA TEST (K915551)Ortho Diagnostic Systems, Inc.1992-04-22
HSV-1 IGG ELISA TEST (K910954)Gull Laboratories, Inc.1991-05-28
HSV-2 IGG ELISA TEST (K910952)Gull Laboratories, Inc.1991-05-28
HSV-2 IGM ELISA TEST (K910953)Gull Laboratories, Inc.1991-05-28
HSV-1 IGM ELISA TEST (K910955)Gull Laboratories, Inc.1991-05-28
IMMUNODIAGNOSTIC ASSAY SYSTEM HERPES SIMPLEX VIRUS (K910499)Vitek Systems, Inc.1991-05-01
KODAK SURECELL HERPES (HSV) CONTROL FLUID SET (K903926)Eastman Kodak Company1990-09-17
SEROCARD HSV IGG ANTIBODY TEST KIT (K903070)Disease Detection International, Inc.1990-08-09
HERPTRAN CONCENTRATE (K900713)E.I. Dupont DE Nemours & Co., Inc.1990-05-11
IDEIA HERPES SIMPLEX VIRUS TEST (K871877)Boots-Celltech Diagnostics, Inc.1989-11-17
MODIFIED DDI SEROCARD HERPES IGG TEST KIT (K884246)Disease Detection International, Inc.1989-04-10
KODAK SURECELL HERPES (HSV) TEST KIT (K884680)Eastman Kodak Company1989-02-16
ELISA FOR HERPES SIMPLEX VIRUS (K843077)Scientific Research1985-06-21
ABBOTT HSV EIA (K843622)Abbott Laboratories1985-05-20
HSV ANTIGEN ELISA KIT (K834449)Ortho Diagnostic Systems, Inc.1984-05-02
HERPELISA KIT (K822883)M.A. Bioproducts1983-07-26
TEST KIT FOR DETECTION OF HERPES SIMPLEX (K802526)Bartels & Stout, Inc.1981-02-09

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