|
Device | Alinity i AFP Reagent Kit |
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 | S026 |
Date Received | 08/11/2023 |
Decision Date | 11/08/2023 |
Product Code |
LOK |
Advisory Committee |
Immunology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the release of Alinity i AFP for use with Alinity i (Alinity ci-series single and multimodule configuration) when connected to the GLP systems Track. |