OYY

Leukemia Translocation Panel Multiplex Test

Product code: OYY
Device name: Leukemia Translocation Panel Multiplex Test
Device class: Class N
Medical specialty: Unknown
Marketing pathway: Contact ODE

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Official FDA classification page: OYY

Classification and pathway per current FDA publications. Data from openFDA (CC0).