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To obtain a substantial equivalence determination for the FilmArray Pneumonia Panel plus
B. Purpose for Submission: To obtain a substantial equivalence determination for the FilmArray Pneumonia Panel. C. Measurand:.
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To obtain a substantial equivalence determination for the FilmArray BCID2 Control Panel M416. B Measurand: Multi-analyte quality control materials.

作者:DM Webber被引用次数:27 — 510(k) substantial equivalence determination summary K180966: FilmArray pneumonia panel. US Department of Health and Human Services, ...
Cultures were reported as “upper respiratory flora” if only normal upper respiratory microbiota were isolated in the absence of significant pathogens. Tracheal ...
作者:CN Murphy2020被引用次数:33 — The ability to provide timely identification of the causative agents of lower ... The BioFire FilmArray Pneumonia Panel (PN panel) and Pneumonia Plus Panel ...
The BioFire Pneumonia Panel delivers fast, accurate pathogen identification in about one hour, which may allow physicians to put patients on appropriate ...
缺少字词: substantialequivalence
作者:CC Ginocchio2021被引用次数:3 — This study compared standard of care testing (SOC) to BioFire® FilmArray® Pneumonia plus Panel (PNplus). PNplus detects 15 bacteria with ...
作者:KH Rand2021被引用次数:5 — Rapid methods for the diagnosis of bacterial pneumonia have been primarily ... The recently FDA-cleared BioFire FilmArray Pneumonia (PN) panel (BioFire ...
2021年6月2日 — Request PDF | Evaluation of the BioFire® FilmArray® Pneumonia Panel for Detection of Viral and Bacterial Pathogens in Lower Respiratory ...
P0571 Analytical reactivity of the FilmArray® Pneumonia Panel plus for identification of viruses, bacteria and antimicrobial resistance genes from lower ...
缺少字词: substantial ‎| 必须包含: substantial

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