PMA
BP000009: Calypte HIV-1 Urine EIA
FDA PMA · Hiv detection test · Maxim Biomedical Inc
Key facts
| PMA number | BP000009 |
|---|---|
| Trade name | Calypte HIV-1 Urine EIA |
| Generic name | Hiv detection test |
| Applicant | Maxim Biomedical Inc |
| Owner/operator | MAXIM BIOMEDICAL INC. |
| Product code | MZF |
| Approval date | Jan 12, 2001 |
| Establishment registration | 1122236 |
| FEI number | 1122236 |
At a glance
- 1–9 Supplements
- Apr 1, 2015 Latest supplement decision
- No Withdrawn
- No Summary of safety and effectiveness on file
- 1–9 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: