ePlex KT022279

GUDID 00857167005283

ePlex Blood Culture Identification Fungal Pathogen (FP) Cartridge Pouch

GENMARK DIAGNOSTICS, INC.

Multiple Candida/yeast species culture isolate identification IVD, kit Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry
Primary Device ID00857167005283
NIH Device Record Keybe261bcc-e804-4f21-96b9-bca7a727d93d
Commercial Distribution StatusIn Commercial Distribution
Brand NameePlex
Version Model NumberBCID_FP Cartridge Pouch
Catalog NumberKT022279
Company DUNS962104217
Company NameGENMARK DIAGNOSTICS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100857167005283 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PEOFungal Organisms, Nucleic Acid-Based Assay

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-08-30
Device Publish Date2019-08-22

On-Brand Devices [ePlex]

00857167005337ePlex Blood Culture Identification Gram Positive (GP) Panel Cartridge Pouch
00857167005320ePlex Blood Culture Identification Gram Positive (GP) Panel 12-Kit Box
00857167005313ePlex Blood Culture Identification Gram Negative (GN) Panel 12-test kit box
00857167005306ePlex Blood Culture Identification Gram Negative (GN) Cartridge Pouch
00857167005290ePlex Blood Culture Identification Fungal Pathogen (FP) 12-test kit box
00857167005283ePlex Blood Culture Identification Fungal Pathogen (FP) Cartridge Pouch
00857167005009ePlex System Base

Trademark Results [ePlex]

Mark Image

Registration | Serial
Company
Trademark
Application Date
EPLEX
EPLEX
88605064 not registered Live/Pending
National Environmental Museum
2019-09-05
EPLEX
EPLEX
88492433 not registered Live/Pending
GenMark Diagnostics, Inc.
2019-06-27
EPLEX
EPLEX
86658228 5266472 Live/Registered
GenMark Diagnostics, Inc.
2015-06-10
EPLEX
EPLEX
86193254 5241784 Live/Registered
GenMark Diagnostics, Inc.
2014-02-13
EPLEX
EPLEX
78465310 not registered Dead/Abandoned
GeneOhm Sciences, Inc.
2004-08-10
EPLEX
EPLEX
75960157 not registered Dead/Abandoned
Dell Computer Corporation
2000-03-14
EPLEX
EPLEX
75599058 not registered Dead/Abandoned
Karl J. Straub
1998-12-11
EPLEX
EPLEX
73324897 1215715 Dead/Cancelled
Evans Products Company
1981-08-24

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