PMA P980041S021
- Device
- ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS
- Applicant
- Beckman Coulter, Inc.
- PMA number
- P980041
- Supplement
- S021
- Product code
- LOK
- Decision date
- 2013-02-06
- Classification
- Kit, Test, Alpha-fetoprotein For Neural Tube Defects
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Approval order statement
- CHANGE TO THE SPECIAL CLEAN MAINTENANCE PROCEDURE THAT MITIGATES VITAMIN B 12 CARRYOVER FROM A WASH BUFFER/ METHANOL COMBINATION TO A METHANOL/DI COMBINATION AND ALSO TO USE ETHANOL AND METHANOL INTERCHANGEABLY AS PART OF THE SPECIAL CLEAN MAINTENANCE PROCEDURE. THIS SPECIAL CLEAN PROCEDURE WOULD BE USED WITH THE ACCESS AFP, HYBRITECH FREE PSA,HYBRITECH PSA AND HYBRITECH P2PSA REAGENTS ON THE ACCESS, ACCESS 2, SYNCHRON LXI 725, AND UNICEL DXC 600I INTEGRATED CLINICAL SYSTEMS.
Current openFDA PMA Record#
- Device
- ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS
- Applicant
- Beckman Coulter, Inc.
- PMA number
- P980041
- Supplement
- S021
- Product code
- LOK
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Decision date
- 2013-02-06
- Decision code
- OK30
- Date received
- 2013-01-03
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE TO THE SPECIAL CLEAN MAINTENANCE PROCEDURE THAT MITIGATES VITAMIN B 12 CARRYOVER FROM A WASH BUFFER/ METHANOL COMBINATION TO A METHANOL/DI COMBINATION AND ALSO TO USE ETHANOL AND METHANOL INTERCHANGEABLY AS PART OF THE SPECIAL CLEAN MAINTENANCE PROCEDURE. THIS SPECIAL CLEAN PROCEDURE WOULD BE USED WITH THE ACCESS AFP, HYBRITECH FREE PSA,HYBRITECH PSA AND HYBRITECH P2PSA REAGENTS ON THE ACCESS, ACCESS 2, SYNCHRON LXI 725, AND UNICEL DXC 600I INTEGRATED CLINICAL SYSTEMS.