Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1
FDA product code MXJ · Class II (moderate risk) · 21 CFR 866.3305 · Microbiology
20510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K213987 | ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG ControlsMXJ · Traditional | Biokit, S.A. | 09/20/2023SE |
| K220923 | Elecsys HSV-1 IgG (08948844160)MXJ · Traditional | Roche Diagnostics | 10/12/2022SE |
| K181333 | ADVIA Centaur Herpes-1 IgGMXJ · Traditional | Biokit, S.A. | 08/23/2018SE |
| K162276 | SeraQuest Herpes Type 1 Specific IgGMXJ · Traditional | Quest International, Inc. | 10/01/2016SE |
| K143236 | Theranos Herpes Simplex Virus-1 IgG AssayMXJ · Traditional | Theranos, Inc. | 07/02/2015SE |
| K131334 | Herpes Simplex Virus Type 1 Igg Elisa TestMXJ · Traditional | Gold Standard Diagnostics | 02/28/2014SE |
| K120625 | Elecsys HSV-1 Igg Immunoassay Elecsys Precicontrol HSVMXJ · Traditional | Roche Diagnostics | 07/25/2012SE |
| K120959 | Bioplex 2200 HSV-1 and HSV-2 Igg KitMXJ · Traditional | Bio-Rad Laboratories | 06/22/2012SE |
| K103363 | Zeus Elisa HSV Gc-I Igg Test SystemMXJ · Traditional | Zeus Scientific, Inc. | 04/26/2011SE |
| K090409 | Bioplex 2200 HSV-1 and HSV-2 Igg on the Bioplex 2200 Multi-Analyte Detection SystemMXJ · Traditional | Bio-Rad Laboratories | 05/08/2009SE |
| K081685 | Liaison HSV-1 Type Specific Igg Assay, Control HSV-1 IggMXJ · Traditional | DiaSorin, Inc. | 11/18/2008SE |
| K072178 | Athena Multi-Lyte HSV 1 & 2 Igg Test SystemMXJ · Traditional | Zeus Scientific, Inc. | 05/30/2008SE |
| K071511 | Plexus Herpeselect 1 and 2 Igg (with Plexus TM Software), Model MP0900GMXJ · Traditional | Focus Diagnostics, Inc. | 10/05/2007SE |
| K071510 | Herpeselect Express Igg, Herpeselect Express Controls, Models RT0920G, RT0950MXJ · Traditional | Focus Diagnostics, Inc. | 09/24/2007SE |
| K062543 | Herpeselect 1 and 2 Plexus Igg, Model MP0900GMXJ · Traditional | Focus Diagnostics, Inc. | 02/01/2007SE |
| K033105 | Captia HSV 1 Igg Type Specific Elisa KitMXJ · Traditional | Trinity Biotech USA | 07/13/2004SE |
| K021486 | Herpeselect 2 Elisa Igg, Model ELO920GMXJ · Traditional | Focus Technologies, Inc. | 08/01/2002SE |
| K021429 | Herpeselect 1 Elisa Igg, Model EL0910GMXJ · Traditional | Focus Technologies, Inc. | 07/29/2002SE |
| K993754 | HSV-1 Elisa Igg, Model EL0910GMXJ · Traditional | Mrl Diagnostics | 02/09/2000SE |
| K984343 | Premier Type Specific HSV-1 Igg Elisa TestMXJ · Traditional | Meridian Diagnostics, Inc. | 06/25/1999SE |