- Device
- ARCHITECT AFP and Alinity i AFP
- Applicant
- Abbott Laboratories
- PMA number
- P120008
- Supplement
- S016
- Product code
- LOK
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Decision date
- 2020-11-05
- Decision code
- OK30
- Date received
- 2020-10-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Adding a process for overhead tank mixing of paramagnetic microparticles using the 650 L microparticle tank in order to improve the manufacturing flexibility of the assays.