PMA supplement
P010033 S037: QuantiFeron TB Gold and QuantiFeron TB Gold Plus
FDA PMA supplement · 135 Review Track For 30-Day Notice · Qiagen
Key facts
| Original PMA | P010033 |
|---|---|
| Supplement number | S037 |
| Supplement type | 135 Review Track For 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | QuantiFeron TB Gold and QuantiFeron TB Gold Plus |
| Generic name | TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS |
| Applicant | Qiagen |
| Product code | NCD |
| Received date | Jan 11, 2018 |
| Decision date | Aug 24, 2018 |
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: