MYF — Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2 Class II
FDA Device Classification
Classification Details
- Product Code
- MYF
- Device Class
- Class II
- Regulation Number
- 866.3305
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K243575 | biokit | ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG Control | February 12, 2025 |
| K220924 | roche diagnostics | Elecsys HSV-2 IgG (08948887160) | October 12, 2022 |
| K181514 | quest international | SeraQuest HSV Type 2 Specific IgG | June 13, 2019 |
| K181334 | biokit | ADVIA Centaur Herpes-2 IgG | August 23, 2018 |
| K152353 | quest international | SeraQuest HSV Type 2 Specific IgG | May 13, 2016 |
| K103603 | zeus scientific | ZEUS ELISA HSV GG-2 IGG TEST SYSTEM | May 20, 2011 |
| K081687 | diasorin | LIAISON HSV-2 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-2 IGG | November 10, 2008 |
| K061239 | euroimmun us | EUROIMMUN ANTI-HSV-2 ELISA (IGG) AND ANTI-HSV-1 ELISA (IGG) KIT | June 28, 2007 |
| K033106 | trinity biotech usa | CAPTIA HSV 2 IGG TYPE SPECIFIC ELISA KIT | July 13, 2004 |
| K993724 | mrl diagnostics | HSV-2 ELISA IGG, MODEL EL0920G | February 1, 2000 |