PMA supplement
BP000009 S008: Calypte HIV-1 Urine EIA
FDA PMA supplement · Normal 180 Day Track · Maxim Biomedical Inc
Key facts
| Original PMA | BP000009 |
|---|---|
| Supplement number | S008 |
| Supplement type | Normal 180 Day Track |
| Trade name | Calypte HIV-1 Urine EIA |
| Generic name | Hiv detection test |
| Applicant | Maxim Biomedical Inc |
| Product code | MZF |
| Received date | Aug 28, 2002 |
| Decision date | Dec 20, 2002 |
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: