PMA supplement
P010033 S047: QuantiFERON®-TB Gold, QuantiFERON®-TB Gold Plus
FDA PMA supplement · Normal 180 Day Track · Qiagen
Key facts
| Original PMA | P010033 |
|---|---|
| Supplement number | S047 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | QuantiFERON®-TB Gold, QuantiFERON®-TB Gold Plus |
| Generic name | TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS |
| Applicant | Qiagen |
| Product code | NCD |
| Received date | Mar 26, 2021 |
| Decision date | Dec 13, 2021 |
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: