PMA
P030049: ADVIA CENTAUR HBSAG READY PACK REAGENTS/CONFIRMATORY READY PACK REAGENTS/QUALITY CONTROL MATERIAL
FDA PMA · Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) · Siemens Healthcare Diagnostics
Key facts
| PMA number | P030049 |
|---|---|
| Trade name | ADVIA CENTAUR HBSAG READY PACK REAGENTS/CONFIRMATORY READY PACK REAGENTS/QUALITY CONTROL MATERIAL |
| Generic name | Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) |
| Applicant | Siemens Healthcare Diagnostics |
| Owner/operator | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Product code | LOM |
| Approval date | May 26, 2005 |
| Docket number | 05M-0270 |
| Notice date | Jul 1, 2005 |
| Establishment registration | 1219913 |
| FEI number | 1219913 |
At a glance
- 10–99 Supplements
- Mar 11, 2021 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- No Withdrawn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: