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FDA 510(k)

ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel

K-Number: K213236 · 2022-04-27

ApplicantGenmark Diagnostics, Incorporated
Decision Date2022-04-27
Product CodePEN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel is a medical device manufactured by Genmark Diagnostics, Incorporated. It received FDA 510(k) clearance on 2022-04-27 under approval number K213236. The device is classified under product code PEN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel?

ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel is a medical device that received FDA 510(k) clearance on 2022-04-27. It is manufactured by Genmark Diagnostics, Incorporated. The 510(k) number is K213236.

When was ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel approved by the FDA?

ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel received FDA 510(k) clearance on 2022-04-27, under approval number K213236.

What company makes ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel?

ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel is manufactured by Genmark Diagnostics, Incorporated.

What is the FDA product code for ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel?

The FDA product code for ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel is PEN.

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Other Devices by Genmark Diagnostics, Incorporated

K152612eSensor Warfarin Sensitivity Saliva Test K163636ePlex Respiratory Pathogen Panel K163652ePlex Instrument K182690ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) Panel K181663ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel K182619ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel

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Related Devices (Code: PEN)

K160457FilmArray Blood Culture Identification (BCID) panel for use with FilmArray TorchBiofire Diagnostics, LLC K181493FilmArray Blood Culture Identification (BCID) 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 K193519BioFire Blood Culture Identification 2 (BCID2) PanelBiofire Diagnostics, LLC K243759BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack) RFIT-ASY-0148 (6 pack))Biofire Diagnostics, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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