Tinaquant 2Microglobulin 11660551216

GUDID 04015630900152

Roche Diagnostics GmbH

Beta-2-microglobulin IVD, kit, nephelometry/turbidimetry

• Primary Device ID: 04015630900152
• NIH Device Record Key: 08a426f6-3914-429d-bc44-6de05b6fb7e9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tinaquant 2Microglobulin
• Version Model Number: 11660551216
• Catalog Number: 11660551216
• 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	04015630900152 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K980724

FDA Product Code

• JZG: SYSTEM, TEST, BETA-2-MICROGLOBULIN IMMUNOLOGICAL

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: 2022-10-10
• Device Publish Date: 2016-09-20

On-Brand Devices [Tinaquant 2Microglobulin]

• 04015630928781: 5950783190
• 04015630900152: 11660551216