PMA supplement
BP050009 S007: Clearview COMPLETE HIV 1/2 ASSAY; Clearview HIV Reactive/Nonreactive Controls
FDA PMA supplement · 135 Day Track for 30 Day Notification · Chembio Diagnostic Systems, In
Key facts
| Original PMA | BP050009 |
|---|---|
| Supplement number | S007 |
| Supplement type | 135 Day Track for 30 Day Notification |
| Trade name | Clearview COMPLETE HIV 1/2 ASSAY; Clearview HIV Reactive/Nonreactive Controls |
| Generic name | Point of care hiv serology diagnostic and/or supplemental test |
| Applicant | Chembio Diagnostic Systems, In |
| Product code | QSU |
| Received date | Oct 24, 2007 |
| Decision date | Feb 11, 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: