|
Device | ADVIA Centaur (XP/XPT, CP) AFP; Atellica IM AFP |
Generic Name | KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS |
Applicant | SIEMENS HEALTHCARE DIAGNOSTICS INC. 333 CONEY STREET EAST WALPOLE, MA 02032 |
PMA Number | P930036 |
Supplement Number | S020 |
Date Received | 09/01/2022 |
Decision Date | 09/30/2022 |
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 Manufacturing process change to the affinity purification method used to purify the anti-AFP polyclonal antibodies (Lite Reagent). |