FDA product code MYM: Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igm
MYM is the FDA product code for assay,enzyme linked immunosorbent,parvovirus b19 igm. It is a Class III device, reviewed by the Microbiology panel. Devices under MYM reach the market by PMA; FDA lists no cleared 510(k)s for it. 3 PMA applications cite this product code. FDA has posted 1 recall for MYM devices.
Classification
| Field | Value |
|---|---|
| Device name | Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igm |
| Device class | Class III |
| Review panel | MI — Microbiology |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for MYM devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2019-08-12.
| Year | Recalls |
|---|---|
| 2019 | 1 |
Frequently asked questions
What is FDA product code MYM?
MYM is the FDA product code for assay,enzyme linked immunosorbent,parvovirus b19 igm. It is a Class III device, reviewed by the Microbiology panel.
What device class is MYM?
Class III. Typical premarket route: PMA.
Have MYM devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2019-08-12.
Next steps
- Run an FDA pathway report with predicate devices for product code MYM
- Run a recall and safety report across every MYM manufacturer
- Watch product code MYM 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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