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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device bcr/abl1 quantitative monitoring test
Definition The bcr/abl1 quantitative monitoring test is a quantitative in vitro diagnostic device used to monitor the bcr/abl1 to abl1 ratio by reverse-transcriptase quantitative polymerase chain reaction (rq-pcr) on whole blood or bone marrow of diagnosed philadelphia chromosome positive (ph+) chronic myeloid leukemia (cml) patients expressing b2a2, b3a2 or e1a2 fusion transcripts. It is intended for use as an aid in the assessment of complete cytogenetic response (ccyr) and major molecular response (mmr) .
Product CodeOYX
Device Class Not Classified