OYY — Leukemia Translocation Panel Multiplex Test Class N
FDA product code OYY covers "Leukemia Translocation Panel Multiplex Test", a Class N medical device. Submissions are reviewed by the Unknown panel.
Classification Details
- Product Code
- OYY
- Device Class
- Class N
- Regulation Number
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Unknown
- Implant
- No
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.