eSensor® XT-8 MT005101

GUDID 00857167005115

eSensor® Respiratory Viral Panel Amplification Reagents (48)

GENMARK DIAGNOSTICS, INC.

Multiple respiratory virus antigen IVD, kit, multiplex

• Primary Device ID: 00857167005115
• NIH Device Record Key: dcf72221-b3ab-496e-9133-14a1750ea0f2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: eSensor® XT-8
• Version Model Number: eSensor® Respiratory Viral Panel (RVP)
• Catalog Number: MT005101
• 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	00857167005115 [Primary]

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-24

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• 00857167005047: eSensor® Warfarin Sensitivity Test Cartridge Pouch (WST) (8)