PMA
BP090080: ARCHITECT HIV Ag/Ab Combo Assay
FDA PMA · Hiv detection test · Abbott Laboratories
Key facts
| PMA number | BP090080 |
|---|---|
| Trade name | ARCHITECT HIV Ag/Ab Combo Assay |
| Generic name | Hiv detection test |
| Applicant | Abbott Laboratories |
| Owner/operator | ABBOTT LABORATORIES |
| Product code | MZF |
| Approval date | Jun 18, 2010 |
| Establishment registration | 1415939 |
| FEI number | 1415939 |
At a glance
- 10–99 Supplements
- Mar 16, 2022 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- No Withdrawn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: