PMA supplement
BP000028 S018: VERSANT HIV-1 RNA 3.0 Assay (bDNA)
FDA PMA supplement · Normal 180 Day Track · Siemens Medical Solutions Diag
Key facts
| Original PMA | BP000028 |
|---|---|
| Supplement number | S018 |
| Supplement type | Normal 180 Day Track |
| Trade name | VERSANT HIV-1 RNA 3.0 Assay (bDNA) |
| Generic name | Hiv detection test |
| Applicant | Siemens Medical Solutions Diag |
| Product code | MZF |
| Received date | Aug 14, 2007 |
| Decision date | Jun 30, 2008 |
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: