Product code MYL
- Device name
- Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg
- 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 |
|---|---|---|---|
| P220034S008 | LIAISON® Biotrin Parvovirus B19 IgG Plus, LIAISON® Biotrin Control Parvovirus B19 IgG Plus | DiaSorin, Inc. | 2025-12-19 |
| P220034S007 | LIAISON® Biotrin Parvovirus B19 IgG Plus, LIAISON® Biotrin Control Parvovirus B19 IgG Plus | DiaSorin, Inc. | 2025-10-10 |
| P220034S004 | LIAISON Biotrin Parvovirus B19 IgG Plus, LIAISON Biotrin Control Parvovirus B19 IgG Plus | DiaSorin, Inc. | 2025-04-25 |
| P220034S006 | LIAISON Biotrin Parvovirus B19 IgG Plus, LIAISON Biotrin Control Parvovirus B19 IgG Plus | DiaSorin, Inc. | 2025-04-10 |
| P220034S005 | -LIAISON Biotrin Parvovirus B19 IgG Plus; LIAISON Biotrin Control Parvovirus B19 IgG Plus | DiaSorin, Inc. | 2025-02-25 |
| P970054S022 | Parvovirus B 19 IgG Enzyme Immunoassay | Diasorin | 2025-01-06 |
| P220034S003 | LIAISON Biotrin Parvovirus B19 lgG Plus and LIAISON Biotrin Control Parvovirus B19 IgG Plus | DiaSorin, Inc. | 2025-01-06 |
| P970054S021 | Parvovirus B19 IgG Enzyme Immunoassay | Diasorin | 2024-07-12 |
| P220034S002 | LIAISON® Biotrin Parvovirus B 19 IgG Plus, LIAISON® Biotrin Control Parvovirus B 19 IgG Plus | DiaSorin, Inc. | 2024-07-12 |
| P220034S001 | LIAISON Biotrin Parvovirus B19 IgG Plus, LIAISON Biotrin Control Parvovirus B19 IgG Plus | DiaSorin, Inc. | 2024-06-04 |
| P220034 | LIAISON Biotrin Parvovirus B19 IgG Plus, LIAISON Biotrin Control Parvovirus B19 IgG Plus | DiaSorin, Inc. | 2024-03-29 |
| P970054S020 | Parvovirus B19 IgG Enzyme Immunoassay | Diasorin | 2021-12-21 |
| P970054S019 | Parvovirus B19 IgG Enzyme Immunoassay | Diasorin | 2020-08-13 |
| P970054S018 | Parvovirus B19 IgG Enzyme Immunoassay | Diasorin | 2020-04-21 |
| P970054S015 | Parvovirus B19 IgG Enzyme Immunoassay (V519IGUS) | Diasorin | 2019-06-13 |
| P150045 | ZEUS ELISA PARVOVIRUS B19 IGG TEST SYSTEM | Zeus Scientific, Inc. | 2017-09-19 |
| P970054S013 | Parvovirus B19 IgG Enzyme Immunoassay | Diasorin | 2017-03-09 |
| P970054S012 | PARVOVIRUS B19 IGG ENZYME IMMUNOASSAY (V5191GUS) | Diasorin | 2017-01-19 |
| P970054S011 | PARVOVIRUS B19 IgG ENZYME IMMUNOASSAY (V519GUS) | Diasorin | 2016-03-03 |
| P970054S010 | PARVOVIRUS B19 IGG ENZYME IMMUNOASSAY | Diasorin | 2013-12-23 |
| P970054S009 | BIOTRIN INTERNATIONAL'S PARVOVIRUS B19 IGG ENZYME IMMUNOASSAY | Diasorin | 2012-09-05 |
| P970054S008 | BIOTRIN INTERNATIONAL'S PARVOVIRUS B19 IGG IN VITRO DIAGNOSTIC DEVICE | Diasorin | 2010-03-19 |
| P970054S007 | BIOTRIN INTERNATIONALS PARVOVIRUS B19 IGG IN VITRO DIAGNOSTIC DEVICE | Diasorin | 2009-03-03 |
| P970054S005 | PARVOVIRUS B19 IGG ENZYME IMMUNOASSAY | Diasorin | 2007-10-10 |
| P970054S006 | PARVOVIRUS B19 IGG ENZYME IMMUNOASSAY | Diasorin | 2007-08-24 |
| P970054S004 | IGG ENZYME IMMUNOASSAY | Diasorin | 2007-06-08 |
| P970054S002 | PARVOVIRUS B19 IGG ENZYME IMMUNOASSAY | Diasorin | 2005-04-01 |
| P970054S001 | BIOTRON PARVOVIRUS B19 IGG ENZYME IMMUNOASSAY | Diasorin | 2003-01-09 |
| P970054 | BIOTRIN PARVOVIRUS B19 IGG | Diasorin | 1999-08-06 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08056771104029 | LIAISON® Biotrin Parvovirus B19 IgG Plus | DIASORIN SPA | 2024-04-08 |
| 08056771104036 | LIAISON® Biotrin Control Parvovirus B19 IgG Plus | DIASORIN SPA | 2024-04-08 |