Product Approval Information

Proper Name: Antibody to Hepatitis B Surface Antigen (Mouse Monoclonal IgM);
                           Antibody to Hepatitis B Surface Antigen (Human)
Tradename: ABBOTT PRISM HBsAg;
                       ABBOTT PRISM HBsAg Confirmatory
Manufacturer: Abbott Laboratories, License #0043

Screening Test Package Insert (PDF - 234 KB) - July, 2006
Confirmatory Test Package Insert (PDF - 150 KB) - July, 2006


Date: July 18, 2006
Indication: The ABBOTT PRISM HBsAg is intended to be used as a screening test for individual human donors, including volunteer donors of whole blood and blood components, and other living donors for the presence of HBsAg. It is also intended for use in testing blood and plasma to screen organ donors when specimens are obtained while the donor's heart is still beating, and in testing blood specimens to screen cadaveric (non-heart-beating) donors.
ABBOTT PRISM HBsAg Confirmatory assay is an in vitro qualitative chemiluminescent (ChLIA) used to confirm the presence of hepatitis B surface antigen (HBsAg) in human serum and plasma by means of specific antibody neutralization. The ABBOTT PRISM HBsAg Confirmatory assay is intended for confirmation of samples found to be repeatedly reactive by the ABBOTT PRISM HBsAg assay.
July 18, 2006 Approval Letter
FDA Approves the First Fully Automated Screening and Confirmatory Tests for Hepatitis B Surface Antigen - July 18, 2006

 
Updated: July 19, 2006