PMA supplement
BP050010 S008: Clearview HIV 1/2 STAT-PAK Assay
FDA PMA supplement · 30-Day Notice · Chembio Diagnostic Systems, In
Key facts
| Original PMA | BP050010 |
|---|---|
| Supplement number | S008 |
| Supplement type | 30-Day Notice |
| Trade name | Clearview HIV 1/2 STAT-PAK Assay |
| Generic name | Point of care hiv serology diagnostic and/or supplemental test |
| Applicant | Chembio Diagnostic Systems, In |
| Product code | QSU |
| Received date | Feb 15, 2008 |
| Decision date | Mar 12, 2008 |
At a glance
- No Expedited review granted
- No Approval order on file
- No Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: