|
Device | Architect AFP and Alinity i AFP |
Generic Name | KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS |
Applicant | Abbott Laboratories 09V6 AP5-2N 100 ABBOTT PARK ROAD ABBOTT PARK, IL 60064 |
PMA Number | P120008 |
Supplement Number | S028 |
Date Received | 01/09/2024 |
Decision Date | 01/30/2024 |
Product Code |
LOK |
Advisory Committee |
Immunology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement approval for an alternate test method for testing of purity of the purchased material Mouse Immunoglobulin G (IgG) |