FDA device listing
Parvovirus B19 IgM Enzyme Immunoassay
FDA device listing 1360371867 · DiaSorin Inc.
Key facts
| Proprietary names | Parvovirus B19 IgM Enzyme Immunoassay |
|---|---|
| Owner/operator | DiaSorin Inc. |
| Owner/operator number | 9051149 |
| Premarket submissions | P970055 |
| Product codes | MYM |
| Device names | MYM - Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igm |
| Device class | Class III |
| Classification regulations (21 CFR) | ORCA1.MYM |
| Review panels | Microbiology |
| Registered establishments | DiaSorin Italia S.p.A. |
| Establishment registrations | 9610240 |
| FEI numbers | 3002808212 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database