|
Device | Acess AFP Reagents on the Access Immunoassay Systems |
Generic Name | KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS |
Applicant | BECKMAN COULTER, INC. 250 SOUTH KRAEMER BLVD M/S W-110 BREA, CA 92822 |
PMA Number | P980041 |
Supplement Number | S043 |
Date Received | 04/03/2019 |
Decision Date | 05/28/2020 |
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 to optimize the metal ion ratios in order to support stable alkaline phosphatase activity in the conjugate diluent used in the Access AFP Reagents. |