Blood Bank Reagents from Biotest Cleared
A line of blood bank reagents from Biotest Diagnostics Corporation received final approval from the Food and Drug Administration. These are designated for use at hospitals, reference laboratories, and blood donor centers.
The reagents are utilized to complete testing for blood serology groups. Those that were approved include Biotestcell Reagent Red Blood Cells, Anti-Human Globulins, Control Sera and Red Cells, Enhancement Reagents, Rare Typing Reagents, and Seraclone Blood Grouping Reagents.
All of the antisera included in the newly approved reagents are monoclonal. A majority of these clones have not been previously available in the United States. The company has a reputation for producing reagents with high levels of both specificity and sensitivity.
The tests complement the existing line of automated reagents from Biotest that work with the company’s TANGOloptimo Automated Blood Bank System, which was also recently approved. A wider range of reagents allow for some cost-effective alternatives. The company notes the importance of providing blood banks with more cost effective solutions, as the transfusion medicine market becomes increasingly competitive.
The parent company of Biotest Diagnostics is Biotest AG, which is based in Germany. Biotest specializes in the development and manufacturing of both automated and tradition blood bank solutions.
August 19, 2008 Related topics: Laboratory, Product Approval & Certification, Laboratory Equipment, Diagnostic