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Biotest Diagnostics wins FDA approval for blood bank reagents

Biotest Diagnostics, the US subsidiary of Germany-based Biotest, has received final clearance from the FDA to begin marketing its full line of traditional blood bank reagents in North America.

Intended for use by donor centers, reference laboratories and hospitals for blood group serology testing, these traditional blood bank reagents complement Biotest’s existing portfolio of automated reagents that work with its Tango|optimo automated blood bank system.

The traditional reagents that received FDA clearance include, Seraclone blood grouping reagents, Biotestcell reagent red blood cells, rare typing reagents, anti-human globulins, enhancement reagents and control sera and red cells.

Bill Weiss, president of Biotest, said: “The approval of our traditional reagent line provides laboratory professionals with a vital alternative for their testing needs.”