Panels › Microbiology › Product code MXJ · Class 2
Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1
Regulation 866.3305
0510(k)s in 12 months (20 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in MXJ
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 20, 2023 | K213987 | ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG Controls Biokit, S.A., ES | MXJ |
| Oct 12, 2022 | K220923 | Elecsys HSV-1 IgG (08948844160) Roche Diagnostics | MXJ |
| Aug 23, 2018 | K181333 | ADVIA Centaur Herpes-1 IgG Biokit, S.A., ES | MXJ |
| Oct 1, 2016 | K162276 | SeraQuest Herpes Type 1 Specific IgG Quest International, Inc. | MXJ |
| Jul 2, 2015 | K143236 | Theranos Herpes Simplex Virus-1 IgG Assay Theranos, Inc. | MXJ |
| Feb 28, 2014 | K131334 | HERPES SIMPLEX VIRUS TYPE 1 IGG ELISA TEST Gold Standard Diagnostics | MXJ |
| Jul 25, 2012 | K120625 | ELECSYS HSV-1 IGG IMMUNOASSAY ELECSYS PRECICONTROL HSV Roche Diagnostics | MXJ |
| Jun 22, 2012 | K120959 | BIOPLEX 2200 HSV-1 AND HSV-2 IGG KIT Bio-Rad Laboratories | MXJ |
| Apr 26, 2011 | K103363 | ZEUS ELISA HSV GC-I IGG TEST SYSTEM Zeus Scientific, Inc. | MXJ |
| May 8, 2009 | K090409 | BIOPLEX 2200 HSV-1 AND HSV-2 IGG ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM Bio-Rad Laboratories | MXJ |
| Nov 18, 2008 | K081685 | LIAISON HSV-1 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-1 IGG DiaSorin, Inc. | MXJ |
| May 30, 2008 | K072178 | ATHENA MULTI-LYTE HSV 1 & 2 IGG TEST SYSTEM Zeus Scientific, Inc. | MXJ |
| Oct 5, 2007 | K071511 | PLEXUS HERPESELECT 1 AND 2 IGG (WITH PLEXUS TM SOFTWARE), MODEL MP0900G Focus Diagnostics, Inc. | MXJ |
| Sep 24, 2007 | K071510 | HERPESELECT EXPRESS IGG, HERPESELECT EXPRESS CONTROLS, MODELS RT0920G, RT0950 Focus Diagnostics, Inc. | MXJ |
| Feb 1, 2007 | K062543 | HERPESELECT 1 AND 2 PLEXUS IGG, MODEL MP0900G Focus Diagnostics, Inc. | MXJ |
| Jul 13, 2004 | K033105 | CAPTIA HSV 1 IGG TYPE SPECIFIC ELISA KIT Trinity Biotech USA | MXJ |
| Aug 1, 2002 | K021486 | HERPESELECT 2 ELISA IGG, MODEL ELO920G Focus Technologies, Inc. | MXJ |
| Jul 29, 2002 | K021429 | HERPESELECT 1 ELISA IGG, MODEL EL0910G Focus Technologies, Inc. | MXJ |
| Feb 9, 2000 | K993754 | HSV-1 ELISA IGG, MODEL EL0910G Mrl Diagnostics | MXJ |
| Jun 25, 1999 | K984343 | PREMIER TYPE SPECIFIC HSV-1 IGG ELISA TEST Meridian Diagnostics, Inc. | MXJ |
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