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U.S. Department of Health and Human Services

Product Classification

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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.
Physical State Mulitplex qualitative chromosome translocation amplification test system. Should not include products not intended for export only or for products intended for re-importation into the USA
Technical Method The test uses a multiplex reverse-transcriptase polymerase chain reaction (RT-PCR) with multiplex fluorescent real-time PCR or bead-based array detection system
Target Area Peripheral human whole blood or bone marrow
Review Panel Immunology
Product CodeOYY
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Not Classified Reason For Export Only
Submission Type Contact ODE
Device Class Not Classified
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible