FDA Proposes 510(k) Exemption for Flow Cytometry Instruments
The agency’s exemption would apply only to cytometry instruments used for counting or characterizing cells.
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Search Results for: hematology
FDA Approves Procleix Babesia Assay for Donor Screening
Assay enables screening for the presence of four clinically relevant species of the Babesia parasite in donated blood.
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FDA Grants Clearance for OGT’s AML/MDS FISH Probes
Clearance enables accurate and easy-to-interpret AML and MDS detection with reduced validation burden.
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Sysmex America UN-2000 Available in the United States and Canada
A powerful combination of automated urine microscopy and digital imaging produces greater accuracy while reducing manual intervention time.
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Clinical Laboratory Connectivity
Adoption of the new standards for laboratory connectivity has broad benefits for all stakeholders in the healthcare ecosystem.
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