ARCHITECT AFP assay
FDA premarket approval P120008/S012 · decided 2018-12-13
Approval details
- PMA number
- P120008
- Supplement
- S012
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ARCHITECT AFP assay
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Applicant
- Abbott Laboratories
- Date received
- 2018-11-13
- Decision date
- 2018-12-13
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- LOK
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Abbott Park, IL
- Statement
- Manufacturing changes to the rare reagent cell culture harvest process and purification process used to prepare the microparticle concentrate.
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