510(k) for Biometrics' cell counter:
This article was originally published in Clinica
Mountain View, California-based Biometrics Imaging has received 510(k) clearance from the FDA for its STELLer CD34+ assay. The assay measures the number of CD34+ cells in a patient's peripheral blood sample and is used in conjunction with Biometric's IMAGN 2000 microvolume fluorimeter. The two devices together determine the optimum time to harvest cells from the patient's peripheral blood sample and whether enough stem cells have been collected for successful grafting.
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