Elecsys Troponin T Gen 5 08469890160

GUDID 07613336158982

Roche Diagnostics GmbH

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• Primary Device ID: 07613336158982
• NIH Device Record Key: afe61fbb-aed1-4488-bde5-40bd6e181932
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Elecsys Troponin T Gen 5
• Version Model Number: 08469890160
• Catalog Number: 08469890160
• 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: false
• 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	07613336158982 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201441

FDA Product Code

• MMI: IMMUNOASSAY METHOD, TROPONIN SUBUNIT

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-10-01
• Device Publish Date: 2021-09-23

On-Brand Devices [Elecsys Troponin T Gen 5]

• 07613336148273: 08250472160
• 07613336158982: 08469890160
• 07613336158951: Troponin T G5 STAT Elecsys cobas e100 V2 (E1G)