eSensor® XT-8 MT002015

GUDID 00857167005153

eSensor® Cystic Fibrosis (CF) Genotyping Test (24)

GENMARK DIAGNOSTICS, INC.

Cystic fibrosis IVD, kit, multiplex

• Primary Device ID: 00857167005153
• NIH Device Record Key: 9c60e621-39b5-46b1-8cf2-334629356ca5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: eSensor® XT-8
• Version Model Number: eSensor® Cystic Fibrosis (CF)
• Catalog Number: MT002015
• 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	00857167005153 [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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• 00857167005245: eSensor® Warfarin Sensitivity Test Amplification Reagents (24)
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• 00857167005221: eSensor® Thrombophilia Risk Test Amplification Reagents (TRT) (48)
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• 00857167005191: eSensor® Thrombophilia Risk Test Cartridge Pouch (TRT) (8)
• 00857167005184: eSensor® Cystic Fibrosis Genotyping Test Reagent Pack (CF) (24)
• 00857167005177: eSensor® Cystic Fibrosis Genotyping Test Detection Reagents (CF) (24)
• 00857167005160: eSensor® Cystic Fibrosis Genotyping Test Amplification Reagents (CF) (24)
• 00857167005153: eSensor® Cystic Fibrosis (CF) Genotyping Test (24)
• 00857167005146: eSensor® Cystic Fibrosis Genotyping Test Cartridge Pouch (CF) (8)
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• 00857167005122: eSensor® Respiratory Viral Panel Detection Reagents (RVP) (48)
• 00857167005115: eSensor® Respiratory Viral Panel Amplification Reagents (48)
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• 00857167005092: eSensor® Respiratory Viral Panel Cartridge Pouch (RVP) (8)
• 00857167005061: eSensor® Warfarin Sensitivity Test Cartridges (WST) (24)
• 00857167005047: eSensor® Warfarin Sensitivity Test Cartridge Pouch (WST) (8)