This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
| Device | QUANTITOPE 125I AFP KIT AND CONTROL SERUM |
| Generic Name | Kit, Test, Alpha-fetoprotein For Neural Tube Defects |
| Applicant | Bio-Rad Laboratories, Inc. |
| Date Received | 1980-05-13 |
| Decision Date | 1984-01-13 |
| Notice Date | 1985-02-17 |
| PMA | P800025 |
| Supplement | S |
| Product Code | LOK |
| Docket Number | 84M-0032 |
| Advisory Committee | Immunology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Bio-Rad Laboratories, Inc. 3 Boulevard Raymond Poincare' marnes-la-coquette 92430 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P800025 | Original Filing | |
| S005 | 1995-12-21 | Normal 180 Day Track |
| S004 | 1986-03-18 | |
| S003 | 1985-04-01 | |
| S002 | ||
| S001 | 1984-01-26 |