AccessGUDID - DEVICE: ePlex System (00857167005016)

GUDID

Device Identifier (DI) Information

Brand Name: ePlex System
Version or Model: ePlex Respiratory Panel (RP)
Commercial Distribution Status: In Commercial Distribution
Catalog Number: KT022287
Company Name: GENMARK DIAGNOSTICS, INC.

Primary DI Number: 00857167005016
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 962104217 *Terms of Use

Device Description: Respiratory Panel Cartridge

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Multiple respiratory virus antigen IVD, kit, multiplex	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or multiple antigens from viruses associated with respiratory diseases in a clinical specimen, using a multiplex method. Viruses intended to be detected may include respiratory syncytial virus (RSV), influenza viruses, parainfluenza viruses, human metapneumovirus, coronaviruses, enteroviruses, rhinoviruses and/or adenoviruses.

GMDN Preferred Term Name

GMDN Definition

Multiple respiratory virus antigen IVD, kit, multiplex

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or multiple antigens from viruses associated with respiratory diseases in a clinical specimen, using a multiplex method. Viruses intended to be detected may include respiratory syncytial virus (RSV), influenza viruses, parainfluenza viruses, human metapneumovirus, coronaviruses, enteroviruses, rhinoviruses and/or adenoviruses.

FDA Product Code

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Product Code	Product Code Name
OZY	Chlamydophila Pneumoniae Dna Assay System
OZX	Mycoplasma Pneumoniae Dna Assay System
OZE	Influenza A And Influenza B Multiplex Nucleic Acid Assay
OTG	Non-Sars Coronavirus Multiplex Nucleic Acid Assay
OQW	2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification
OOU	Parainfluenza Multiplex Nucleic Acid Assay
OEP	Influenza A Virus Subtype Differentiation Nucleic Acid Assay
OEM	Human Metapneumovirus (Hmpv) Rna Assay System
OCC	Respiratory Virus Panel Nucleic Acid Assay System

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K163636	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

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Storage and Handling
No storage/handling found

Clinically Relevant Size

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Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f24cb749-b64e-414e-bbc1-feea8a9e04aa
Public Version Date: August 23, 2019
Public Version Number: 3
DI Record Publish Date: January 03, 2018