Access AFP Reagents on the Access Immunoassay Systems
FDA premarket approval P980041/S040 · decided 2018-09-12
Approval details
- PMA number
- P980041
- Supplement
- S040
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Access AFP Reagents on the Access Immunoassay Systems
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Applicant
- Beckman Coulter, Inc.
- Date received
- 2018-08-13
- Decision date
- 2018-09-12
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- LOK
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Brea, CA
- Statement
- Manufacturing change (cell culture) to the AFP reagent antibody production process for increased productivity (batch size) and improved capacity.
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