FDA product code MYF: Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2
MYF is the FDA product code for enzyme linked immunosorbent assay, herpes simplex virus, hsv-2. It is a Class II device, regulated under 21 CFR 866.3305 and reviewed by the Microbiology panel. FDA has cleared 10 510(k) submissions under MYF, 2 in the last five years, from 8 different applicants. The average 510(k) review took 212 days (median 179); 85 days on average over the last three years. FDA has posted 2 recalls for MYF devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2 |
| Device class | Class II |
| Regulation | 21 CFR 866.3305 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
510(k) clearances per year for MYF
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 94 |
| 2019 | 1 | 370 |
| 2022 | 1 | 195 |
| 2025 | 1 | 85 |
Compare with all 510(k) review times · Search every MYF clearance
Top MYF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Biokit, S.A. | 2 | 2025-02-12 |
| Quest International, Inc. | 2 | 2019-06-13 |
| Roche Diagnostics | 1 | 2022-10-12 |
| Zeus Scientific, Inc. | 1 | 2011-05-20 |
| DiaSorin, Inc. | 1 | 2008-11-10 |
3 more applicants have MYF clearances. See the full list in Caduvo.
Most recent MYF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K243575 | Biokit, S.A. | ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG Controls | 2025-02-12 | 85 |
| K220924 | Roche Diagnostics | Elecsys HSV-2 IgG (08948887160) | 2022-10-12 | 195 |
| K181514 | Quest International, Inc. | SeraQuest HSV Type 2 Specific IgG | 2019-06-13 | 370 |
| K181334 | Biokit, S.A. | ADVIA Centaur Herpes-2 IgG | 2018-08-23 | 94 |
| K152353 | Quest International, Inc. | SeraQuest HSV Type 2 Specific IgG | 2016-05-13 | 267 |
Recalls for MYF devices
2 product recalls in 2 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2023-12-13.
| Year | Recalls |
|---|---|
| 2021 | 1 |
| 2023 | 1 |
Frequently asked questions
What is FDA product code MYF?
MYF is the FDA product code for enzyme linked immunosorbent assay, herpes simplex virus, hsv-2. It is a Class II device, regulated under 21 CFR 866.3305 and reviewed by the Microbiology panel.
What device class is MYF?
Class II, regulation 21 CFR 866.3305. Typical premarket route: 510(k).
How long does a 510(k) take for product code MYF?
Across 10 cleared submissions the average was 212 days from receipt to decision (median 179).
Which companies have the most MYF clearances?
Biokit, S.A. (2); Quest International, Inc. (2); Roche Diagnostics (1); Zeus Scientific, Inc. (1); DiaSorin, Inc. (1).
Have MYF devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2023-12-13.
Next steps
- Run an FDA pathway report with predicate devices for product code MYF
- Run a recall and safety report across every MYF manufacturer
- Watch product code MYF for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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