FDA product code OYY: Leukemia Translocation Panel Multiplex Test
OYY is the FDA product code for leukemia translocation panel multiplex test. It is a Not classified device, reviewed by the Immunology panel. Devices under OYY reach the market by Contact FDA; FDA lists no cleared 510(k)s for it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Leukemia Translocation Panel Multiplex Test |
| Device class | Not classified |
| Review panel | IM — Immunology |
| Medical specialty | Unknown |
| Premarket route | Contact FDA |
Recalls for OYY devices
openFDA lists no recalls for product code OYY.
Frequently asked questions
What is FDA product code OYY?
OYY is the FDA product code for leukemia translocation panel multiplex test. It is a Not classified device, reviewed by the Immunology panel.
What device class is OYY?
Not classified. Typical premarket route: Contact FDA.
Next steps
- Run an FDA pathway report with predicate devices for product code OYY
- Run a recall and safety report across every OYY manufacturer
- Watch product code OYY for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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