Total Bilirubin 11822713216

GUDID 04015630991266

Roche Diagnostics GmbH

Total bilirubin IVD, kit, spectrophotometry Total bilirubin IVD, kit, spectrophotometry Total bilirubin IVD, kit, spectrophotometry Total bilirubin IVD, kit, spectrophotometry Total bilirubin IVD, kit, spectrophotometry Total bilirubin IVD, kit, spectrophotometry Total bilirubin IVD, kit, spectrophotometry Total bilirubin IVD, kit, spectrophotometry Total bilirubin IVD, kit, spectrophotometry Total bilirubin IVD, kit, spectrophotometry Total bilirubin IVD, kit, spectrophotometry Total bilirubin IVD, kit, spectrophotometry Total bilirubin IVD, kit, spectrophotometry Total bilirubin IVD, kit, spectrophotometry Total bilirubin IVD, kit, spectrophotometry

• Primary Device ID: 04015630991266
• NIH Device Record Key: 29b10e42-61fe-429d-8528-9630f28a49b3
• Commercial Distribution Discontinuation: 2018-04-17
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Total Bilirubin
• Version Model Number: 11822713216
• Catalog Number: 11822713216
• 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
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04015630991266 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K063543

FDA Product Code

• CIG: DIAZO COLORIMETRY, BILIRUBIN

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2023-07-06
• Device Publish Date: 2016-09-20

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