PMA
BP010009: Cambridge Biotech HIV-1 Urine Western Blot
FDA PMA · Hiv detection test · Maxim Biomedical Inc
Key facts
| PMA number | BP010009 |
|---|---|
| Trade name | Cambridge Biotech HIV-1 Urine Western Blot |
| Generic name | Hiv detection test |
| Applicant | Maxim Biomedical Inc |
| Owner/operator | MAXIM BIOMEDICAL INC. |
| Product code | MZF |
| Approval date | Jun 21, 2001 |
| Establishment registration | 1122236 |
| FEI number | 1122236 |
At a glance
- 10–99 Supplements
- Apr 17, 2006 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- No Withdrawn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: