FDA product code MYL: Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg
MYL is the FDA product code for assay,enzyme linked immunosorbent,parvovirus b19 igg. It is a Class III device, reviewed by the Microbiology panel. Devices under MYL reach the market by PMA; FDA lists no cleared 510(k)s for it. 3 PMA applications cite this product code. FDA has posted 3 recalls for MYL devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg |
| Device class | Class III |
| Review panel | MI — Microbiology |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for MYL devices
3 product recalls in 2 recall events; 2 initiated in the last five years and 3 still open. Most recent: 2023-10-31.
| Year | Recalls |
|---|---|
| 2020 | 1 |
| 2023 | 2 |
Frequently asked questions
What is FDA product code MYL?
MYL is the FDA product code for assay,enzyme linked immunosorbent,parvovirus b19 igg. It is a Class III device, reviewed by the Microbiology panel.
What device class is MYL?
Class III. Typical premarket route: PMA.
Have MYL devices been recalled?
Yes: 3 product recalls across 2 recall events; the most recent began 2023-10-31.
Next steps
- Run an FDA pathway report with predicate devices for product code MYL
- Run a recall and safety report across every MYL manufacturer
- Watch product code MYL 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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