PMA
P060034: BIO RAD MONOLISA ANTI-HBC IGM EIA
FDA PMA · Qualitative and Quantitative Hepatitis B Virus Antibody assays · Bio-Rad Laboratories, Inc.
Key facts
| PMA number | P060034 |
|---|---|
| Trade name | BIO RAD MONOLISA ANTI-HBC IGM EIA |
| Generic name | Qualitative and Quantitative Hepatitis B Virus Antibody assays |
| Applicant | Bio-Rad Laboratories, Inc. |
| Owner/operator | BIO-RAD LABORATORIES, INC. |
| Product code | SEI |
| Approval date | May 31, 2007 |
| Docket number | 07M-0254 |
| Notice date | Jun 28, 2007 |
| Establishment registration | 3007886270 |
| FEI number | 3008272466 |
At a glance
- 1–9 Supplements
- Mar 19, 2014 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- No Withdrawn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: