MYF
10 FDA 510(k) clearances · Product code
195 daysmedian time to decision
421 days90th percentile
10clearances measured
FDA profile
- Official device name
- Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3305
- Medical specialty
- Microbiology
- Adverse events (MAUDE)
- 2023: 252 · 2025: 43 · 2026: 26
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG Controls (K243575) | Biokit, S.A. | 2025-02-12 |
| Elecsys HSV-2 IgG (08948887160) (K220924) | Roche Diagnostics | 2022-10-12 |
| SeraQuest HSV Type 2 Specific IgG (K181514) | Quest International, Inc. | 2019-06-13 |
| ADVIA Centaur Herpes-2 IgG (K181334) | Biokit, S.A. | 2018-08-23 |
| SeraQuest HSV Type 2 Specific IgG (K152353) | Quest International, Inc. | 2016-05-13 |
| ZEUS ELISA HSV GG-2 IGG TEST SYSTEM (K103603) | Zeus Scientific, Inc. | 2011-05-20 |
| LIAISON HSV-2 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-2 IGG (K081687) | DiaSorin, Inc. | 2008-11-10 |
| EUROIMMUN ANTI-HSV-2 ELISA (IGG) AND ANTI-HSV-1 ELISA (IGG) KIT (K061239) | Euroimmun Us, LLC | 2007-06-28 |
| CAPTIA HSV 2 IGG TYPE SPECIFIC ELISA KIT (K033106) | Trinity Biotech USA | 2004-07-13 |
| HSV-2 ELISA IGG, MODEL EL0920G (K993724) | Mrl Diagnostics | 2000-02-01 |
Track MYF automatically
Every clearance here is in the API, with alerts when new ones post.