510(k) Report

Devices descending from DEN120014

14 later devices reach Verigene Gram Positive Blood Culture Nucleic Acid Test (BC-GP) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K152470Great Basin Staph ID/R Blood Culture PanelGreat Basin Scientific, Inc.201601
+1K122514Verigene Gram-Positive Blood Culture (GC-GP) Nucleic Acid TestNanosphere, Inc.2012128
+2K243490LIAISON PLEX Gram-Positive Blood Culture AssayLuminex Corporation20250—
+2K163390iC-GPC Assay TM for use on the iC-SystemTMIcubate, Inc.20170—
+2K132843Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN)Nanosphere, Inc.201428
+2K130914Filmarray Blood Culture Identification (Bcid) PanelBiofire Diagnostics, Inc.201396
+3K243013LIAISON PLEX Gram-Negative Blood Culture AssayLuminex Corporation20250—
+3K190341iC-GN iC-Cassette for use on the iC-SystemIcubate, Inc.20190—
+3K182690ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) PanelGenmark Diagnostics, Incorporated20182—
+3K181663ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) PanelGenmark Diagnostics, Incorporated20181—
+3K143171FilmArray Blood Culture Identification (BCID) Panel for use with the FilmArray 2.0Biofire Diagnostics, LLC201515
+4K254194QIAstat-Dx BCID GPF Plus AMR PanelQIAGEN GmbH20260—
+4K240627LIAISON PLEX Yeast Blood Culture AssayLuminex Corporation20240—
+4K160457FilmArray Blood Culture Identification (BCID) panel for use with FilmArray TorchBiofire Diagnostics, LLC201605