Hemostasis Analyzer Receives De Novo Marketing Authorization
The system leverages innovative ultrasound technology to provide rapid viscoelastic results in 15 minutes or less.
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Search Results for: hematology
CMS Renews Deeming Authority for COLA
The renewal applies to specialties that include clinical chemistry, diagnostic immunology, hematology, immunohematology, and microbiology.
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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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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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