PMA
P940034: GEN-PROBE(R) AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD TEST)
FDA PMA · System, nucleic acid amplification, mycobacterium tuberculosis complex · Gen-Probe, Inc.
Key facts
| PMA number | P940034 |
|---|---|
| Trade name | GEN-PROBE(R) AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD TEST) |
| Generic name | System, nucleic acid amplification, mycobacterium tuberculosis complex |
| Applicant | Gen-Probe, Inc. |
| Owner/operator | HOLOGIC, INC. |
| Product code | MWA |
| Approval date | Dec 15, 1995 |
| Docket number | 97M-0184 |
| Notice date | Jun 18, 1997 |
| Establishment registration | 2024800 |
| FEI number | 2024800 |
At a glance
- 10–99 Supplements
- Dec 5, 2012 Latest supplement decision
- No Withdrawn
- No Summary of safety and effectiveness on file
- None 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: