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Leukemia Translocation Panel Multiplex Test

OYY · Not classified · Unknown

Classification

FDA Product Code
OYY
Device class
Not classified
Regulation
Review panel
IM
Medical specialty
Unknown
Submission type
3
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N

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.

Market data

Cleared 510(k) submissions
0
Registered establishments
0

Source

Authoritative
FDA Device Classification database
Machine
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