|
Device | AUOTDELFIA HAFP KIT |
Generic Name | KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS |
Applicant | PerkinElmer, Inc. 940 Winter Street Waltham, MA 02451 |
PMA Number | P970037 |
Supplement Number | S007 |
Date Received | 09/23/2011 |
Decision Date | 04/27/2012 |
Product Code |
LOK |
Advisory Committee |
Immunology |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A CHANGE OF THE DISPENSING LINE USED IN THE MANUFACTURING OF THE CALIBRATORS FOR THE AUTODELFIA AND DELFIA XPRESS HAFP KITS AND THE BUFFER SOLUTION FOR THE DELFIA XPRESS HAFP KIT. |