Anti-Tg CalSet 09005030160

GUDID 07613336203538

Roche Diagnostics GmbH

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• Primary Device ID: 07613336203538
• NIH Device Record Key: f6366895-c2da-4b0b-b572-70ad21d658d1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Anti-Tg CalSet
• Version Model Number: 09005030160
• Catalog Number: 09005030160
• Company DUNS: 315028860
• Company Name: Roche Diagnostics GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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	07613336203538 [Primary]

FDA Product Code

• JIS: Calibrator, primary

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: 2023-11-08
• Device Publish Date: 2023-10-31

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