PMA
P090008: ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON COBAS E601 IMMUNOSSAY ANALYZER
FDA PMA · Assay, enzyme linked immunosorbent, hepatitis c virus · Roche Diagnostics Corp.
Key facts
| PMA number | P090008 |
|---|---|
| Trade name | ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON COBAS E601 IMMUNOSSAY ANALYZER |
| Generic name | Assay, enzyme linked immunosorbent, hepatitis c virus |
| Applicant | Roche Diagnostics Corp. |
| Owner/operator | Roche Diagnostics Operations Inc. |
| Product code | MZO |
| Approval date | Apr 29, 2010 |
| Docket number | 10M-0262 |
| Notice date | Jun 14, 2010 |
| Establishment registration | 9610529 |
| FEI number | 3002806560 |
At a glance
- 10–99 Supplements
- Jan 24, 2023 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- No Withdrawn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: