PMA
BP050009: Chembio HIV Reactive/Nonreactive Controls; SURE CHECK HIV 1/2 ASSAY
FDA PMA · Point of care hiv serology diagnostic and/or supplemental test · Chembio Diagnostic Systems, In
Key facts
| PMA number | BP050009 |
|---|---|
| Trade name | Chembio HIV Reactive/Nonreactive Controls; SURE CHECK HIV 1/2 ASSAY |
| Generic name | Point of care hiv serology diagnostic and/or supplemental test |
| Applicant | Chembio Diagnostic Systems, In |
| Owner/operator | CHEMBIO DIAGNOSTIC SYSTEMS, INC. |
| Product code | QSU |
| Approval date | May 25, 2006 |
| Establishment registration | 2431980 |
| FEI number | 2431980 |
At a glance
- 10–99 Supplements
- May 16, 2016 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- No Withdrawn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: