Panels › Microbiology › Product code MYF · Class 2
Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2
Regulation 866.3305
0510(k)s in 12 months (10 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in MYF
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 12, 2025 | K243575 | ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG Controls Biokit, S.A., ES | MYF |
| Oct 12, 2022 | K220924 | Elecsys HSV-2 IgG (08948887160) Roche Diagnostics | MYF |
| Jun 13, 2019 | K181514 | SeraQuest HSV Type 2 Specific IgG Quest International, Inc. | MYF |
| Aug 23, 2018 | K181334 | ADVIA Centaur Herpes-2 IgG Biokit, S.A., ES | MYF |
| May 13, 2016 | K152353 | SeraQuest HSV Type 2 Specific IgG Quest International, Inc. | MYF |
| May 20, 2011 | K103603 | ZEUS ELISA HSV GG-2 IGG TEST SYSTEM Zeus Scientific, Inc. | MYF |
| Nov 10, 2008 | K081687 | LIAISON HSV-2 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-2 IGG DiaSorin, Inc. | MYF |
| Jun 28, 2007 | K061239 | EUROIMMUN ANTI-HSV-2 ELISA (IGG) AND ANTI-HSV-1 ELISA (IGG) KIT Euroimmun Us, LLC | MYF |
| Jul 13, 2004 | K033106 | CAPTIA HSV 2 IGG TYPE SPECIFIC ELISA KIT Trinity Biotech USA | MYF |
| Feb 1, 2000 | K993724 | HSV-2 ELISA IGG, MODEL EL0920G Mrl Diagnostics | MYF |
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