PMA
P020022: BAYER VERSANT (TM) HCV RNA 3.0 ASSAY (BDNA)
FDA PMA · Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus · Siemens Healthcare Diagnostics, Inc.
Key facts
| PMA number | P020022 |
|---|---|
| Trade name | BAYER VERSANT (TM) HCV RNA 3.0 ASSAY (BDNA) |
| Generic name | Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus |
| Applicant | Siemens Healthcare Diagnostics, Inc. |
| Owner/operator | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Product code | MZP |
| Approval date | Mar 28, 2003 |
| Docket number | 04M-0538 |
| Notice date | Dec 8, 2004 |
| Establishment registration | 1219913 |
| FEI number | 1219913 |
At a glance
- 10–99 Supplements
- Dec 23, 2013 Latest supplement decision
- Yes Withdrawn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: