Data / Medical devices / United States / Genmark Diagnostics, Inc.

Genmark Diagnostics, Inc.: FDA-registered device maker in Carlsbad, CA, United States, 5 510(k) clearances

Name: Genmark Diagnostics, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Genmark Diagnostics, Inc. is registered with the FDA (registration 3008632402) in Carlsbad, CA, United States. It lists 15 device types. The FDA files 5 510(k) clearances under its listings, the newest dated April 12, 2019. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3008632402
Address: GenMark Diagnostics, Inc. 5964 La Place Ct, Carlsbad, CA, United States, 92008
Owner or operator: GenMark Diagnostics, Inc. (9056858)
Roles: Manufacturer, Manufacturer for export
First device listed: June 15, 2017
Registered through: 2027
Brand names listed: GenMark ePlex Instrument, cobas® eplex blood culture identification fungal pathogen (BCID-FP) panel, cobas® eplex blood culture identification gram negative (BCID-GN) panel, cobas® eplex blood culture identification gram positive (BCID-GP) panel, cobas® eplex respiratory pathogen (RP) panel, cobas® eplex respiratory pathogen panel 2, cobas® eplex respiratory pathogen panel 3, cobas® eplex system and more

Devices it lists

Device	Product code	Class	Role	Source
2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification	OQW	2	Manufacturer	accessdata.fda.gov
Chlamydophila Pneumoniae Dna Assay System	OZY	2	Manufacturer	accessdata.fda.gov
Fungal Organisms, Nucleic Acid-Based Assay	PEO	2	Manufacturer	accessdata.fda.gov
Gram-Negative Bacteria And Associated Resistance Markers	PEN	2	Manufacturer	accessdata.fda.gov
Gram-Positive Bacteria And Their Resistance Markers	PAM	2	Manufacturer	accessdata.fda.gov
Human Metapneumovirus (Hmpv) Rna Assay System	OEM	2	Manufacturer	accessdata.fda.gov
Influenza A And Influenza B Multiplex Nucleic Acid Assay	OZE	2	Manufacturer	accessdata.fda.gov
Influenza A Virus Subtype Differentiation Nucleic Acid Assay	OEP	2	Manufacturer	accessdata.fda.gov
Instrumentation For Clinical Multiplex Test Systems	NSU	2	Manufacturer	accessdata.fda.gov
Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents	QOF	2	Manufacturer for export	accessdata.fda.gov
Mycoplasma Pneumoniae Dna Assay System	OZX	2	Manufacturer	accessdata.fda.gov
Non-Sars Coronavirus Multiplex Nucleic Acid Assay	OTG	2	Manufacturer	accessdata.fda.gov
Parainfluenza Multiplex Nucleic Acid Assay	OOU	2	Manufacturer	accessdata.fda.gov
Reagents, 2019-Novel Coronavirus Nucleic Acid	QJR	N	Manufacturer	accessdata.fda.gov
Respiratory Virus Panel Nucleic Acid Assay System	OCC	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
April 12, 2019	K182619	ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel	PEN	Substantially Equivalent	Genmark Diagnostics, Incorporated	accessdata.fda.gov
December 21, 2018	K182690	ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) Panel	PEO	Substantially Equivalent	Genmark Diagnostics, Incorporated	accessdata.fda.gov
December 20, 2018	K181663	ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel	PAM	Substantially Equivalent	Genmark Diagnostics, Incorporated	accessdata.fda.gov
June 9, 2017	K163652	ePlex Instrument	NSU	Substantially Equivalent	Genmark Diagnostics, Incorporated	accessdata.fda.gov
June 9, 2017	K163636	ePlex Respiratory Pathogen Panel	OCC	Substantially Equivalent	Genmark Diagnostics, Incorporated	accessdata.fda.gov

Compare with other makers

Updated April 12, 2019. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.