Prealbumin 08252645190

GUDID 07613336147894

Roche Diagnostics GmbH

Prealbumin (transthyretin) IVD, kit, nephelometry/turbidimetry

• Primary Device ID: 07613336147894
• NIH Device Record Key: 09339e9d-7804-4b6d-acc3-511487ecfdb8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Prealbumin
• Version Model Number: 08252645190
• Catalog Number: 08252645190
• 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: 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	07613336147894 [Primary]

FDA Product Code

• JZJ: PREALBUMIN, ANTIGEN, ANTISERUM, CONTROL

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: 2020-03-13
• Device Publish Date: 2020-03-05

On-Brand Devices [Prealbumin]

• 07613336147894: 08252645190
• 04015630928804: 5950902190