PMA
P010033: QUANTTFERON-TB GOLD AND TB GOLD-IN-THE-TUBE
FDA PMA · TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS · Qiagen
Key facts
| PMA number | P010033 |
|---|---|
| Trade name | QUANTTFERON-TB GOLD AND TB GOLD-IN-THE-TUBE |
| Generic name | TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS |
| Applicant | Qiagen |
| Owner/operator | QIAGEN Sciences LLC |
| Product code | NCD |
| Approval date | Nov 28, 2001 |
| Docket number | 02M-0218 |
| Notice date | May 13, 2002 |
| Establishment registration | 1122376 |
| FEI number | 3003572099 |
At a glance
- 10–99 Supplements
- Jan 23, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 10–99 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: