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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 the device name listed in this FDA 510(k) record. The listed applicant is Genmark Diagnostics, Incorporated. It received FDA 510(k) clearance on 2022-04-27 under 510(k) 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. The listed applicant is Genmark Diagnostics, Incorporated. The 510(k) number is K213236.

When did ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel receive FDA 510(k) clearance?

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

Who is the listed applicant for ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel?

The FDA 510(k) record lists Genmark Diagnostics, Incorporated as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Genmark Diagnostics, Incorporated as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K182619ePlex Blood Culture Identification Gram Negative (BCID-GN) PanelK182690ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) PanelK181663ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) PanelK163652ePlex InstrumentK163636ePlex Respiratory Pathogen PanelK152612eSensor Warfarin Sensitivity Saliva Test

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Related Devices (Code: PEN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243013LIAISON PLEX Gram-Negative Blood Culture AssayLuminex CorporationK243759BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack) RFIT-ASY-0148 (6 pack))Biofire Diagnostics, LLCK193519BioFire Blood Culture Identification 2 (BCID2) PanelBiofire Diagnostics, LLCK190341iC-GN iC-Cassette for use on the iC-SystemIcubate, Inc.K182619ePlex Blood Culture Identification Gram Negative (BCID-GN) PanelGenmark Diagnostics, IncorporatedK181493FilmArray Blood Culture Identification (BCID) PanelBiofire 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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