GENMARK DIAGNOSTICS, INC.

FDA Device Registration & Listing · Carlsbad, CA, US · Registration 3008632402

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3008632402
FEI Number
3008632402
Entity Name
GENMARK DIAGNOSTICS, INC.
City/State/Country
Carlsbad, CA, US
Establishment Address
GenMark Diagnostics, Inc., 5964 La Place Ct, Carlsbad, CA 92008, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
GenMark Diagnostics, Inc. (Owner Number: 9056858)
Owner / Operator Contact Address
GenMark Diagnostics, Inc., 5964 La Place Ct, Carlsbad, CA 92008, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K182619
PMA Number
N/A

All Registered Proprietary Names

ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel cobas® eplex blood culture identification gram positive (BCID-GP) panel cobas® eplex respiratory pathogen panel 3 ePlex Blood Culture Identification Fungal Pathogen (BCID-FP) Panel cobas® eplex blood culture identification fungal pathogen (BCID-FP) panel ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel cobas® eplex blood culture identification gram negative (BCID-GN) panel

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
PAM Gram-Positive Bacteria And Their Resistance Markers Microbiology Class 2 866.3365 2019-03-07
PEO Fungal Organisms, Nucleic Acid-Based Assay Microbiology Class 2 866.3365 2019-03-07
PEN Gram-Negative Bacteria And Associated Resistance Markers Microbiology Class 2 866.3365 2019-03-07
QOF Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents Microbiology Class 2 866.3981 2026-04-29
PEN Gram-Negative Bacteria And Associated Resistance Markers Microbiology Class 2 866.3365 2019-03-07
PEO Fungal Organisms, Nucleic Acid-Based Assay Microbiology Class 2 866.3365 2019-03-07
PAM Gram-Positive Bacteria And Their Resistance Markers Microbiology Class 2 866.3365 2019-03-07
PEO Fungal Organisms, Nucleic Acid-Based Assay Microbiology Class 2 866.3365 2019-05-30
PEN Gram-Negative Bacteria And Associated Resistance Markers Microbiology Class 2 866.3365 2019-05-30
PAM Gram-Positive Bacteria And Their Resistance Markers Microbiology Class 2 866.3365 2019-05-30

Official Correspondent

Jeff Boone

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

GenMark Diagnostics, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008632402. Last updated year: 2026. Please use registration number 3008632402 when referencing this establishment in official correspondence.
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