PMA supplement
P970055 S010: BIOTRIN INTERNATIONAL'S PARVOVIRUS B19 IGM ENZYME IMMUNOASSAY
FDA PMA supplement · Normal 180 Day Track No User Fee · Diasorin
Key facts
| Original PMA | P970055 |
|---|---|
| Supplement number | S010 |
| Supplement type | Normal 180 Day Track No User Fee |
| Reason for the supplement | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | BIOTRIN INTERNATIONAL'S PARVOVIRUS B19 IGM ENZYME IMMUNOASSAY |
| Generic name | ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGM |
| Applicant | Diasorin |
| Product code | MYM |
| Received date | Jun 24, 2011 |
| Decision date | Sep 5, 2012 |
At a glance
- No Expedited review granted
- No Approval order on file
- No Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: