PMA P120008S028
- Device
- Architect AFP and Alinity i AFP
- Applicant
- Abbott Laboratories
- PMA number
- P120008
- Supplement
- S028
- Product code
- LOK
- Decision date
- 2024-01-30
- Classification
- Immunology
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Approval order statement
- approval for an alternate test method for testing of purity of the purchased material Mouse Immunoglobulin G (IgG)
Current openFDA PMA Record#
- Device
- Architect AFP and Alinity i AFP
- Applicant
- Abbott Laboratories
- PMA number
- P120008
- Supplement
- S028
- Product code
- LOK
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Decision date
- 2024-01-30
- Decision code
- OK30
- Date received
- 2024-01-09
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval for an alternate test method for testing of purity of the purchased material Mouse Immunoglobulin G (IgG)