|
Device | IMMULITE® AFP, IMMULITE® 2000 AFP |
Generic Name | KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS |
Applicant | SIEMENS HEALTHCARE DIAGNOSTICS INC. 511 BENEDICT AVE. TARRYTOWN, NY 10591 |
PMA Number | P010007 |
Supplement Number | S016 |
Date Received | 03/21/2022 |
Decision Date | 08/30/2023 |
Product Code |
LOK |
Advisory Committee |
Immunology |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the change in labeling to include a limitation regarding interference from the drug STRENSIQ. |