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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device leukemia translocation panel multiplex test
Definition The leukemia translocation panel multiplex test is a qualitative in vitro diagnostic device intended to identify specific fusion transcripts by reverse-transcriptase polymerase chain reaction (rt-pcr) from whole blood or bone marrow. It is intended for use as an aid in the diagnosis of recurrent balanced or reciprocal translocation positive acute and chronic myeloid leukemia, acute lymphocytic or promyelocytic leukemias.
Product CodeOYY
Device Class Not Classified