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Becton, Dickinson and Co.
FDA grants 510(k) clearance for Legionella pneumophila test
June 26th, 2004
BD Diagnostics, a segment of Becton, Dickinson and Company (BDX), announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the BD ProbeTec ET Legionella pneumophila DNA Amplified Assay. Based on BD's proprietary real-time nucleic acid amplification technology, Strand Displacement Amplification (SDA), the Legionella assay is designed for the detection of L. pneumophila (serogroups 1 - 14) and performs amplification and real-time detection in a 1-hour assay format. It is one of several assays under development at BD for the detection of organisms that cause atypical pneumonia. Other assays being submitted to the FDA for the...
Source: Law & Health Weekly (2004-06-26)
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