PMA
P800025: QUANTITOPE 125I AFP KIT AND CONTROL SERUM
FDA PMA · KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS · Bio-Rad Laboratories, Inc.
Key facts
| PMA number | P800025 |
|---|---|
| Trade name | QUANTITOPE 125I AFP KIT AND CONTROL SERUM |
| Generic name | KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS |
| Applicant | Bio-Rad Laboratories, Inc. |
| Owner/operator | Bio-Rad Laboratories, Inc. |
| Product code | LOK |
| Approval date | Jan 13, 1984 |
| Docket number | 84M-0032 |
| Notice date | Feb 17, 1985 |
| Establishment registration | 3010127294 |
| FEI number | 3010127294 |
At a glance
- 1–9 Supplements
- Oct 2, 1996 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- Yes Withdrawn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: