Elecsys CYFRA 21-1 CalSet 11820974322

GUDID 04015630909834

Roche Diagnostics GmbH

Cytokeratin IVD, calibrator

• Primary Device ID: 04015630909834
• NIH Device Record Key: 4092d3d7-2c4c-43ff-9835-0451258b15af
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Elecsys CYFRA 21-1 CalSet
• Version Model Number: 11820974322
• Catalog Number: 11820974322
• 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	04015630909834 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160915

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: 4
• Public Version Date: 2019-04-09
• Device Publish Date: 2016-12-20

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