|Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.|
|Trade Name||ACCESS HYBRITECH P2PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS|
|Applicant||BECKMAN COULTER, INC.|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|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.