PMA supplement
BP000009 S020: Calypte HIV-1 Urine EIA
FDA PMA supplement · 135 Day Track for 30 Day Notification · Maxim Biomedical Inc
Key facts
| Original PMA | BP000009 |
|---|---|
| Supplement number | S020 |
| Supplement type | 135 Day Track for 30 Day Notification |
| Trade name | Calypte HIV-1 Urine EIA |
| Generic name | Hiv detection test |
| Applicant | Maxim Biomedical Inc |
| Product code | MZF |
| Received date | Apr 18, 2005 |
| Decision date | Aug 29, 2005 |
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: