PMA supplement
BP090032 S013: INSTI? HIV-1/HIV-2 Antibody Test
FDA PMA supplement · 135 Day Track for 30 Day Notification · bioLytical Laboratories, Inc
Key facts
| Original PMA | BP090032 |
|---|---|
| Supplement number | S013 |
| Supplement type | 135 Day Track for 30 Day Notification |
| Trade name | INSTI? HIV-1/HIV-2 Antibody Test |
| Generic name | Point of care hiv serology diagnostic and/or supplemental test |
| Applicant | bioLytical Laboratories, Inc |
| Product code | QSU |
| Received date | Apr 1, 2016 |
| Decision date | Nov 17, 2016 |
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: