PWDClass II
Flow Cytometric Test System For Hematopoietic Neoplasms
Hematology · 21 CFR 864.7010
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)
MDR events3All time
Recalls0All time
Registered firms8Currently listed
510(k) clearances2All time
Recent MDR events
3 adverse event reports on file
- BD ONEFLOW PCSTApr 1, 2021MalfunctionBecton, Dickinson And Company, Bd Biosciences2916837-2021-00133
- BD ONEFLOW ALOTAug 26, 2020MalfunctionBecton, Dickinson And Company, Bd Biosciences2916837-2020-00095
- BD ONEFLOW ALOTJul 20, 2020MalfunctionBecton, Dickinson And Company, Bd Biosciences2916837-2020-00060
Event type breakdown
Malfunction3
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
8 firms currently registered for this product code