PMA
BP950002: Home Access HIV-1 Test System
FDA PMA · Hiv testing service · Home Access Health Corporation
Key facts
| PMA number | BP950002 |
|---|---|
| Trade name | Home Access HIV-1 Test System |
| Generic name | Hiv testing service |
| Applicant | Home Access Health Corporation |
| Owner/operator | PWNHealth Chicago, LLC |
| Product code | MVZ |
| Approval date | Jul 22, 1996 |
| Establishment registration | 1423455 |
| FEI number | 3000206414 |
At a glance
- 10–99 Supplements
- Sep 21, 2011 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- No Withdrawn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: