STEMCELL Technologies Announces FDA De Novo Classification for Its EasySep™ CD138 Positive Selection Kit to Support Cancer Diagnostic Tests
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Tuesday, March 26, 2024
Oncology, Health, FDA, Medical Devices, Clinical Trials, Pharmaceutical, Biotechnology, De novo, Stemcell Technologies, Plasma, In situ hybridization, Medicine, Cell, Bone marrow, Partnership, Risk, Patient, Fluorescence, Sale, Classification, Multiple myeloma, DSM-IV codes, B cell, IVD, National Comprehensive Cancer Network, American College, European, FISH, Cancer, CD138, Multimedia, Food, Medical device
STEMCELL Technologies is pleased to announce that its new EasySep™ Human Bone Marrow CD138 Positive Selection Kit has been granted de novo classification by the U.S. Food and Drug Administration (FDA) as a first-of-its-kind in vitro diagnostic (IVD) medical device for hematopoietic cell enrichment.
Key Points:
- STEMCELL Technologies is pleased to announce that its new EasySep™ Human Bone Marrow CD138 Positive Selection Kit has been granted de novo classification by the U.S. Food and Drug Administration (FDA) as a first-of-its-kind in vitro diagnostic (IVD) medical device for hematopoietic cell enrichment.
- View the full release here: https://www.businesswire.com/news/home/20240326396951/en/
STEMCELL Technologies is pleased to announce that its new EasySep™ Human Bone Marrow CD138 Positive Selection Kit is now classified by the U.S. Food and Drug Administration (FDA) as a first-of-its-kind in vitro diagnostic (IVD) medical device for hematopoietic cell enrichment. - (Photo: Business Wire)
The kit can be used to enrich plasma cells expressing the CD138 marker (CD138+ cells) from patient bone marrow samples. - The EasySep™ Human Bone Marrow CD138 Positive Selection Kit will be available for sale in the United States, the European Union, Canada, and the United Kingdom.