CalSet Troponin T Gen 5 08250499160

GUDID 07613336148280

Roche Diagnostics GmbH

Troponin T IVD, calibrator

• Primary Device ID: 07613336148280
• NIH Device Record Key: 29aea095-9010-4091-bdd7-db3c773b3b93
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CalSet Troponin T Gen 5
• Version Model Number: 08250499160
• Catalog Number: 08250499160
• Company DUNS: 315028860
• Company Name: Roche Diagnostics GmbH
• 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: false
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613336148280 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162895

FDA Product Code

• JIT: Calibrator, secondary

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: 2018-07-06
• Device Publish Date: 2017-09-11

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