MYF — Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2 Class II
FDA product code MYF covers "Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2", a Class II medical device regulated under 21 CFR 866.3305. Submissions are reviewed by the Microbiology panel. At least 10 recent 510(k) clearances have been granted under this product code.
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 |