MYM · Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igm
· Class 3
Overview
| Product Code | MYM |
|---|---|
| Device Name | Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igm |
| Device Class | Class 3 |
| Review Panel |
Recent Cleared Devices (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| P250039 | LIAISON Biotrin Parvovirus B19 IgM Plus, LIAISON Biotrin Control Parvovirus B19 IgM Plus | DiaSorin, Inc. | May 7, 2026 | APPR |
| P150042 | ZEUS ELISA PARVOVIRUS B19 IGM TEST SYSTEM | Zeus Scientific, Inc. | Sep 19, 2017 | APPR |
| P970055 | BIOTRIN PARVOVIRUS IGM EIA (V619IMUS) | Diasorin | Aug 6, 1999 | APPR |
Top Applicants
- DiaSorin, Inc. — 1 clearance
- Diasorin — 1 clearance
- Zeus Scientific, Inc. — 1 clearance