|
Device | QUANTITOPE 125I AFP KIT AND CONTROL SERUM |
Generic Name | KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS |
Applicant | Bio-Rad Laboratories, Inc. 3 Boulevard Raymond Poincare' Marnes-la-Coquette 92430 |
PMA Number | P800025 |
Supplement Number | S005 |
Date Received | 12/21/1995 |
Decision Date | 10/02/1996 |
Withdrawal Date
|
04/03/2009 |
Product Code |
LOK |
Advisory Committee |
Immunology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement REPLACEMENT OF THE CURRENT RADIOLABELED AFP WITH A NEW AFP ANTIGEN |