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U.S. Department of Health and Human Services

Product Classification

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Device flow cytometric test system for hematopoietic neoplasms
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)
Physical State Monoclonal and polyclonal antibody cocktails in panels, accessory reagents including software and beads used for analysis and acquisition of data.
Technical Method These reagents provide multiparameter, qualitative results for the Cluster of Differentiation (CD) parameters.
Target Area Whole blood, bone marrow, and lymph node specimens.
Regulation Medical Specialty Hematology
Review Panel Hematology
Product CodePWD
Premarket Review Division of Immunology and Hematology Devices (DIHD)
Division of Immunology and Hematology Devices (DIHD)
Submission Type 510(k)
Regulation Number 864.7010
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons