Bilirubin Direct Gen.2 (Doumas standardization) 05589061190

GUDID 04015630927531

Roche Diagnostics GmbH

Conjugated (direct) bilirubin IVD, kit, spectrophotometry

• Primary Device ID: 04015630927531
• NIH Device Record Key: 85fffc33-0a90-43bc-a988-c369a8ba841b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bilirubin Direct Gen.2 (Doumas standardization)
• Version Model Number: 05589061190
• Catalog Number: 05589061190
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04015630927531 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123965

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: 2023-10-16
• Device Publish Date: 2023-10-06

On-Brand Devices [Bilirubin Direct Gen.2 (Doumas standardization)]

• 04015630927531: 05589061190
• 04015630924912: 05168384190