FDA 510(k) Applications for Medical Device Product Code "MYF"
(Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K181334 | Biokit, S.A. | ADVIA Centaur Herpes-2 IgG | 08/23/2018 |
| K243575 | Biokit, S.A. | ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG Controls | 02/12/2025 |
| K081687 | DIASORIN, INC. | LIAISON HSV-2 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-2 IGG | 11/10/2008 |
| K061239 | EUROIMMUN US LLC | EUROIMMUN ANTI-HSV-2 ELISA (IGG) AND ANTI-HSV-1 ELISA (IGG) KIT | 06/28/2007 |
| K993724 | MRL DIAGNOSTICS | HSV-2 ELISA IGG, MODEL EL0920G | 02/01/2000 |
| K181514 | Quest International, Inc. | SeraQuest HSV Type 2 Specific IgG | 06/13/2019 |
| K152353 | Quest International, Inc. | SeraQuest HSV Type 2 Specific IgG | 05/13/2016 |
| K220924 | Roche Diagnostics | Elecsys HSV-2 IgG (08948887160) | 10/12/2022 |
| K033106 | TRINITY BIOTECH USA | CAPTIA HSV 2 IGG TYPE SPECIFIC ELISA KIT | 07/13/2004 |
| K103603 | ZEUS SCIENTIFIC, INC. | ZEUS ELISA HSV GG-2 IGG TEST SYSTEM | 05/20/2011 |
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