ePlex System KT022287

GUDID 00857167005016

Respiratory Panel Cartridge

GENMARK DIAGNOSTICS, INC.

Multiple respiratory virus antigen IVD, kit, multiplex

• Primary Device ID: 00857167005016
• NIH Device Record Key: f24cb749-b64e-414e-bbc1-feea8a9e04aa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ePlex System
• Version Model Number: ePlex Respiratory Panel (RP)
• Catalog Number: KT022287
• Company DUNS: 962104217
• Company Name: GENMARK DIAGNOSTICS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857167005016 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163636

FDA Product Code

• OZY: Chlamydophila Pneumoniae Dna Assay System

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-08-23
• Device Publish Date: 2018-01-03

On-Brand Devices [ePlex System]

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