Product code MYM
- Device name
- Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igm
- Medical specialty
- Unknown
- Device class
- 3
- Review panel
- MI
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P250039 | LIAISON Biotrin Parvovirus B19 IgM Plus, LIAISON Biotrin Control Parvovirus B19 IgM Plus | DiaSorin, Inc. | 2026-05-07 |
| P970055S024 | Parvovirus B 19 IgM Enzyme Immunoassay | Diasorin | 2025-01-06 |
| P970055S023 | Parvovirus B19 IgM Enzyme Immunoassay | Diasorin | 2024-07-12 |
| P970055S022 | Parvovirus B19 IgM Enzyme Immunoassay | Diasorin | 2021-12-21 |
| P970055S021 | Parvovirus B19 IgM Enzyme Immunoassay | Diasorin | 2020-08-13 |
| P970055S020 | Parvovirus B19 IgM Enzyme Immunoassay | Diasorin | 2020-04-21 |
| P970055S017 | Parvovirus B19 IgM Enzyme Immunoassay (V619IMUS) | Diasorin | 2019-06-13 |
| P970055S019 | Parvovirus B19 IgM Immunoassy (V619IMUS) | Diasorin | 2019-04-17 |
| P150042 | ZEUS ELISA PARVOVIRUS B19 IGM TEST SYSTEM | Zeus Scientific, Inc. | 2017-09-19 |
| P970055S015 | Parvovirus B19 IgM Enzyme Immunoassay | Diasorin | 2017-03-09 |
| P970055S014 | PARVOVIRUS B19 IGM ENZYME IMMUNOASSAY (V619IMUS) | Diasorin | 2017-01-19 |
| P970055S013 | PARVOVIRUS B19 IGM ENZYME IMMUNOASSAY (V619IMUD) | Diasorin | 2013-12-23 |
| P970055S010 | BIOTRIN INTERNATIONAL'S PARVOVIRUS B19 IGM ENZYME IMMUNOASSAY | Diasorin | 2012-09-05 |
| P970055S012 | BIOTRIN PARVOVIRUS B19 IGM ENZYME IMMUNOASSAY | Diasorin | 2011-12-29 |
| P970055S011 | BIOTRIN INTERNATIONAL'S PARVOVIRUS B19 IGM ENZYME IMMUNOASSAY | Diasorin | 2011-08-03 |
| P970055S009 | PARVOVIRUS B19 IGM ENZYME IMMUNOASSAY | Diasorin | 2010-06-10 |
| P970055S008 | BIOTRIN INTERNATIONAL'S PARVOVIRUS B19 IGM IN VITRO DIAGNOSTIC DEVICE | Diasorin | 2010-03-19 |
| P970055S007 | BIOTRIN INTERNATIONAL'S PARVOVIRUS B19 IGM IN VITRO DIAGNOSTIC DEVICE | Diasorin | 2009-03-03 |
| P970055S005 | PARVOVIRUS B19 IGM ENZYME IMMUNOASSAY | Diasorin | 2007-10-10 |
| P970055S006 | PARVOVIRUS B19 IGM ENZYME IMMUNOASSAY | Diasorin | 2007-08-24 |
| P970055S004 | IGM ENZYME IMMUNOASSAY | Diasorin | 2007-06-08 |
| P970055S002 | PARVOVIRUS B19 IGM ENZYME IMMUNOASSAY | Diasorin | 2005-04-01 |
| P970055S001 | BIOTRON PARVOVIRUS B19 IGM ENZYME IMMUNOASSAY | Diasorin | 2003-01-09 |
| P970055 | BIOTRIN PARVOVIRUS IGM EIA (V619IMUS) | Diasorin | 1999-08-06 |