Bilirubin Direct Gen.2 08056951190

GUDID 07613336121061

Roche Diagnostics GmbH

Conjugated (direct) bilirubin IVD, kit, spectrophotometry

• Primary Device ID: 07613336121061
• NIH Device Record Key: 92ba6e08-41f0-47c2-92ce-cb6300f04191
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bilirubin Direct Gen.2
• Version Model Number: 08056951190
• Catalog Number: 08056951190
• 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
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613336121061 [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: 2020-03-13
• Device Publish Date: 2020-03-05

Devices Manufactured by Roche Diagnostics GmbH

• 04015630924288 - sFlT-1 CalSet: 2025-04-15
• 04015630925407 - CalSet PlGF: 2025-04-15
• 07613336172094 - Elecsys sFlT-1: 2025-04-15
• 07613336172124 - Elecsys PlGF: 2025-04-15
• 07613336220108 - PreciControl Rubella IgM: 2025-04-15
• 07613336230671 - Elecsys sFlT-1: 2025-04-15
• 07613336230756 - Elecsys PlGF: 2025-04-15
• 07613336223321 - Kidney KFRE Algorithm: 2025-04-08