PEN

Product Code: PEN


Products Classified as PEN

3558Gram-negative Bacteria And Associated Resistance MarkersMultiplex Nucleic Acid Assay For Identification Of Microorganisms And Resistance Markers From Positive Blood Cultures.

Total Product Life Cycle (TPLC) Devices

3558Gram-negative Bacteria And Associated Resistance MarkersMultiplex Nucleic Acid Assay For Identification Of Microorganisms And Resistance Markers From Positive Blood Cultures.

Pre-market Notifications for PEN

K213236EPlex Blood Culture Identification Gram Negative (BCID-GN) PanelGenMark Diagnostics, Incorporated
K193519BioFire Blood Culture Identification 2 (BCID2) PanelBioFire Diagnostics, LLC
K190341IC-GN IC-Cassette For Use On The IC-SystemICubate, Inc.
K182619EPlex Blood Culture Identification Gram Negative (BCID-GN) PanelGenMark Diagnostics, Incorporated
K181493FilmArray Blood Culture Identification (BCID) PanelBioFire Diagnostics, LLC
K160457FilmArray Blood Culture Identification (BCID) Panel For Use With FilmArray TorchBIOFIRE DIAGNOSTICS, LLC
K143171FilmArray Blood Culture Identification (BCID) Panel For Use With The FilmArray 2.0Biofire Diagnostics, LLC.
K132843VERIGENE GRAM NEGATIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GN)NANOSPHERE, INC
K130914FILMARRAY BLOOD CULTURE IDENTIFICATION (BCID) PANELBIOFIRE DIAGNOSTICS, INC.

Global Unique Device Identification Database

00862011000321Gram-Negative Bacteria And Associated Resistance Markers
00857573006300Gram-Negative Bacteria And Associated Resistance Markers
00857573006249Gram-Negative Bacteria And Associated Resistance Markers
00857573006140Gram-Negative Bacteria And Associated Resistance Markers
B769ICCAAQA00000Gram-Negative Bacteria And Associated Resistance Markers

Maude Adverse Events

VERIGENE GRAM-NEGATIVE BLOOD CULTURE TEST (BC-GN)NANOSPHERE, INC.2019-11-22
VERIGENE GRAM-NEGATIVE BLOOD CULTURE TEST (BC-GN)NANOSPHERE, INC.2019-07-19
FILMARRAY? BLOOD CULTURE IDENTIFICATION (BCID) PANELBIOFIRE DIAGNOSTICS, LLC2019-07-18
FILMARRAY ? BLOOD CULTURE IDENTIFICATION (BCID) PANELBIOFIRE DIAGNOSTICS, LLC2019-04-18
FILMARRAY ? BLOOD CULTURE IDENTIFICATION (BCID) PANELBIOFIRE DIAGNOSTICS, LLC2019-03-12
BIOFIRE FILM ARRAY BLOOD CULTURE IDENTIFICATION PANELBIOMERIEUX / BIOFIRE2018-03-30

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