Bilirubin Direct Gen.2 (Doumas standardization) 05589061190

GUDID 04015630927531

Roche Diagnostics GmbH

Conjugated (direct) bilirubin IVD, kit, spectrophotometry Conjugated (direct) bilirubin IVD, kit, spectrophotometry Conjugated (direct) bilirubin IVD, kit, spectrophotometry Conjugated (direct) bilirubin IVD, kit, spectrophotometry Conjugated (direct) bilirubin IVD, kit, spectrophotometry Conjugated (direct) bilirubin IVD, kit, spectrophotometry Conjugated (direct) bilirubin IVD, kit, spectrophotometry Conjugated (direct) bilirubin IVD, kit, spectrophotometry Conjugated (direct) bilirubin IVD, kit, spectrophotometry Conjugated (direct) bilirubin IVD, kit, spectrophotometry Conjugated (direct) bilirubin IVD, kit, spectrophotometry Conjugated (direct) bilirubin IVD, kit, spectrophotometry Conjugated (direct) bilirubin IVD, kit, spectrophotometry Conjugated (direct) bilirubin IVD, kit, spectrophotometry Conjugated (direct) bilirubin IVD, kit, spectrophotometry Conjugated (direct) bilirubin IVD, kit, spectrophotometry Conjugated (direct) bilirubin IVD, kit, spectrophotometry 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