MYF
- Product code
- MYF
- Device name
- Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2
- Device class
- Class 2
- 21 CFR
- 21 CFR 866.3305
- Medical specialty
- Microbiology
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 1
- Summaries archived here
- 1 (direct download)
- 510(k) clearances (all years, FDA)
- 10 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K243575 | 2025-02-12 | Biokit, S.A. | ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator,… |
Official FDA classification page: MYF
Classification and pathway per current FDA publications. Data from openFDA (CC0).