PWD

Flow Cytometric Test System For Hematopoietic Neoplasms

Product code

PWD

Device name

Flow Cytometric Test System For Hematopoietic Neoplasms

Device class

Class 2

21 CFR

21 CFR 864.7010

Medical specialty

Hematology

Marketing pathway

510(K)

Flag

Third-party review eligible

510(k) clearances (all years, FDA)

2 (all years; only the last 3 years are listed here)

FDA classification definition

Reagents intended for in vitro diagnostic use as a panel for qualitative identification of cell populations by multiparameter immunophenotyping on a flow cytometer. These reagents are used as an aid in the differential diagnosis of hematologically abnormal patients having, or suspected of having the following hematopoietic neoplasms: chronic leukemia, acute leukemia, non-Hodgkin's lymphoma, myeloma, myelodysplastic syndrome (MDS), and/or myeloproliferative neoplasms (MPN)

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