|Trade Name||ACCESS HYBRITECH P2PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS|
|Generic Name||hybritech p2psa reagents on the access immunoassay systems|
|Applicant||BECKMAN COULTER, INC.|
|Supplement Type||real-time process|
|Supplement Reason|| labeling change - indications|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for labeling changes to align with globally harmonized system of classification of chemicals (ghs) which provides a consistent hazard classification system that is recognized globally.