510(k) Report

Devices descending from K130914

9 later devices reach Filmarray Blood Culture Identification (Bcid) Panel through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K182690ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) PanelGenmark Diagnostics, Incorporated20182—
+1K181663ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) PanelGenmark Diagnostics, Incorporated20181—
+1K143171FilmArray Blood Culture Identification (BCID) Panel for use with the FilmArray 2.0Biofire Diagnostics, LLC201515
+1K132843Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN)Nanosphere, Inc.201428
+2K254194QIAstat-Dx BCID GPF Plus AMR PanelQIAGEN GmbH20260—
+2K243013LIAISON PLEX Gram-Negative Blood Culture AssayLuminex Corporation20250—
+2K240627LIAISON PLEX Yeast Blood Culture AssayLuminex Corporation20240—
+2K190341iC-GN iC-Cassette for use on the iC-SystemIcubate, Inc.20190—
+2K160457FilmArray Blood Culture Identification (BCID) panel for use with FilmArray TorchBiofire Diagnostics, LLC201605