PMA
P940040: AMPLICOR (TM) MYCOBACTERIUM TUBERCULOSIS TEST
FDA PMA · System, nucleic acid amplification, mycobacterium tuberculosis complex · Roche Molecular Systems, Inc.
Key facts
| PMA number | P940040 |
|---|---|
| Trade name | AMPLICOR (TM) MYCOBACTERIUM TUBERCULOSIS TEST |
| Generic name | System, nucleic acid amplification, mycobacterium tuberculosis complex |
| Applicant | Roche Molecular Systems, Inc. |
| Owner/operator | Roche Diagnostics Operations Inc. |
| Product code | MWA |
| Approval date | Nov 26, 1996 |
| Docket number | 97M-0125 |
| Notice date | Apr 1, 1997 |
| Establishment registration | 3004141078 |
| FEI number | 2243470 |
At a glance
- 10–99 Supplements
- Nov 25, 2008 Latest supplement decision
- Yes Withdrawn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: