FDA expands clearance for Immunetics' bacteria assay

08/16/2013 | American City Business Journals

The FDA has granted Immunetics expanded clearance for its BacTx test to be used in identifying the presence of bacteria in apheresis platelets. The assay, which was previously cleared for point-of-care screening of platelets derived from whole blood, can now be used as an ancillary tool to transfusion services as well as for quality testing of leukocyte-reduced apheresis platelets within a period of 24 hours after transfusion.

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