Atlas FDA

MXJ

20 FDA 510(k) clearances · Product code

154 daysmedian time to decision
298 days90th percentile
20clearances measured

FDA profile

Official device name
Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1
Device class
Class II (moderate risk)
Regulation
21 CFR 866.3305
Medical specialty
Microbiology
Adverse events (MAUDE)
2023: 140
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG Controls (K213987)Biokit, S.A.2023-09-20
Elecsys HSV-1 IgG (08948844160) (K220923)Roche Diagnostics2022-10-12
ADVIA Centaur Herpes-1 IgG (K181333)Biokit, S.A.2018-08-23
SeraQuest Herpes Type 1 Specific IgG (K162276)Quest International, Inc.2016-10-01
Theranos Herpes Simplex Virus-1 IgG Assay (K143236)Theranos, Inc.2015-07-02
HERPES SIMPLEX VIRUS TYPE 1 IGG ELISA TEST (K131334)Gold Standard Diagnostics2014-02-28
ELECSYS HSV-1 IGG IMMUNOASSAY ELECSYS PRECICONTROL HSV (K120625)Roche Diagnostics2012-07-25
BIOPLEX 2200 HSV-1 AND HSV-2 IGG KIT (K120959)Bio-Rad Laboratories2012-06-22
ZEUS ELISA HSV GC-I IGG TEST SYSTEM (K103363)Zeus Scientific, Inc.2011-04-26
BIOPLEX 2200 HSV-1 AND HSV-2 IGG ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM (K090409)Bio-Rad Laboratories2009-05-08
LIAISON HSV-1 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-1 IGG (K081685)DiaSorin, Inc.2008-11-18
ATHENA MULTI-LYTE HSV 1 & 2 IGG TEST SYSTEM (K072178)Zeus Scientific, Inc.2008-05-30
PLEXUS HERPESELECT 1 AND 2 IGG (WITH PLEXUS TM SOFTWARE), MODEL MP0900G (K071511)Focus Diagnostics, Inc.2007-10-05
HERPESELECT EXPRESS IGG, HERPESELECT EXPRESS CONTROLS, MODELS RT0920G, RT0950 (K071510)Focus Diagnostics, Inc.2007-09-24
HERPESELECT 1 AND 2 PLEXUS IGG, MODEL MP0900G (K062543)Focus Diagnostics, Inc.2007-02-01
CAPTIA HSV 1 IGG TYPE SPECIFIC ELISA KIT (K033105)Trinity Biotech USA2004-07-13
HERPESELECT 2 ELISA IGG, MODEL ELO920G (K021486)Focus Technologies, Inc.2002-08-01
HERPESELECT 1 ELISA IGG, MODEL EL0910G (K021429)Focus Technologies, Inc.2002-07-29
HSV-1 ELISA IGG, MODEL EL0910G (K993754)Mrl Diagnostics2000-02-09
PREMIER TYPE SPECIFIC HSV-1 IGG ELISA TEST (K984343)Meridian Diagnostics, Inc.1999-06-25

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Every clearance here is in the API, with alerts when new ones post.