PMA
P070006: T SPOT-TB TEST
FDA PMA · Mycobacterium tuberculosis, Cell mediated immune response, enzyme-linked immunospot test · Oxford Immunotec, Ltd.
Key facts
| PMA number | P070006 |
|---|---|
| Trade name | T SPOT-TB TEST |
| Generic name | Mycobacterium tuberculosis, Cell mediated immune response, enzyme-linked immunospot test |
| Applicant | Oxford Immunotec, Ltd. |
| Owner/operator | Oxford Immunotec Ltd |
| Product code | OJN |
| Approval date | Jul 30, 2008 |
| Docket number | 08M-0477 |
| Notice date | Aug 26, 2008 |
| Establishment registration | 3015492990 |
| FEI number | 3015492990 |
At a glance
- 10–99 Supplements
- Aug 4, 2025 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 1–9 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: