Bilirubin Direct 20737496322

GUDID 04015630913206

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: 04015630913206
• NIH Device Record Key: 33691bde-de03-45b4-9617-3b0e6cc65d57
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bilirubin Direct
• Version Model Number: 20737496322
• Catalog Number: 20737496322
• 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 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04015630913206 [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: 4
• Public Version Date: 2023-07-06
• Device Publish Date: 2016-09-20

Devices Manufactured by Roche Diagnostics GmbH

• 07613336224816 - ONLINE TDM Methotrexate: 2024-04-02
• 07613336224823 - ONLINE TDM Methotrexate: 2024-04-02
• 07613336224830 - MTX Calibrator: 2024-04-02
• 07613336217689 - Elecsys ProBNP II: 2024-02-27
• 04015630929702 - cobas Elecsys AntiTPO: 2024-02-16
• 04015630939626 - Elecsys Anti-TPO: 2024-02-16
• 04015630899548 - Elecsys CalSet TUptake: 2024-02-05
• 04015630899579 - Elecsys Tuptake Assay: 2024-02-05