PMA P980041S033
- Device
- ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS
- Applicant
- Beckman Coulter, Inc.
- PMA number
- P980041
- Supplement
- S033
- Product code
- LOK
- Decision date
- 2015-07-08
- Classification
- Kit, Test, Alpha-fetoprotein For Neural Tube Defects
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Approval order statement
- MANUFACTURING CHANGES TO THE PRODUCTION AND PURIFICATION PROCESS OF ANTIBODY, WHICH IS USED IN PREPARATION OF THE PARAMAGNETIC PARTICLES FOR USE IN THE ACCESS AFP REAGENT.
Current openFDA PMA Record#
- Device
- ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS
- Applicant
- Beckman Coulter, Inc.
- PMA number
- P980041
- Supplement
- S033
- Product code
- LOK
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Decision date
- 2015-07-08
- Decision code
- OK30
- Date received
- 2015-06-05
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- MANUFACTURING CHANGES TO THE PRODUCTION AND PURIFICATION PROCESS OF ANTIBODY, WHICH IS USED IN PREPARATION OF THE PARAMAGNETIC PARTICLES FOR USE IN THE ACCESS AFP REAGENT.