Bilirubin Total Gen.3 10421436190

GUDID 07613336235522

Roche Diagnostics GmbH

Total bilirubin IVD, kit, spectrophotometry

• Primary Device ID: 07613336235522
• NIH Device Record Key: af7227ac-5d1b-4c48-9798-a05e1df86dcc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bilirubin Total Gen.3
• Version Model Number: 10421436190
• Catalog Number: 10421436190
• 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	07613336235522 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131544

FDA Product Code

• CIG: DIAZO COLORIMETRY, BILIRUBIN

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: 2025-02-10
• Device Publish Date: 2025-01-31

On-Brand Devices [Bilirubin Total Gen.3]

• 07613336121078: 08056960190
• 07613336235522: 10421436190
• 07613336235515: 10421428190
• 07613336235508: 10421410190