ePlex System EA001012

GUDID 00857167005030

ePlex Respiratory Panel Kit, 12 test, IVD

GENMARK DIAGNOSTICS, INC.

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Primary Device ID00857167005030
NIH Device Record Key54c96299-7b9d-4627-b15a-703efee6e057
Commercial Distribution StatusIn Commercial Distribution
Brand NameePlex System
Version Model NumberePlex Respiratory Panel (RP)
Catalog NumberEA001012
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 Kittrue
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
GS100857167005030 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OZYChlamydophila Pneumoniae Dna Assay System

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-08-23
Device Publish Date2017-12-29

On-Brand Devices [ePlex System]

00857167005030ePlex Respiratory Panel Kit, 12 test, IVD
00857167005023ePlex Sample Delivery Device RP Panel
00857167005016Respiratory Panel Cartridge

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