PMA supplement
BP050009 S011: Chembio HIV Reactive/Nonreactive Controls; SURE CHECK HIV 1/2 ASSAY
FDA PMA supplement · Special Supplement · Chembio Diagnostic Systems, In
Key facts
| Original PMA | BP050009 |
|---|---|
| Supplement number | S011 |
| Supplement type | Special Supplement |
| 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 |
| Product code | QSU |
| Received date | Jan 14, 2009 |
| Decision date | Jun 24, 2009 |
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: