Preciset sTfR 12148331122

GUDID 04015630919482

Roche Diagnostics GmbH

Transferrin/transferrin isoform IVD, kit, nephelometry/turbidimetry Transferrin/transferrin isoform IVD, kit, nephelometry/turbidimetry Transferrin/transferrin isoform IVD, kit, nephelometry/turbidimetry Transferrin/transferrin isoform IVD, kit, nephelometry/turbidimetry Transferrin/transferrin isoform IVD, kit, nephelometry/turbidimetry Transferrin/transferrin isoform IVD, kit, nephelometry/turbidimetry Transferrin/transferrin isoform IVD, kit, nephelometry/turbidimetry Transferrin/transferrin isoform IVD, kit, nephelometry/turbidimetry Transferrin/transferrin isoform IVD, kit, nephelometry/turbidimetry Transferrin/transferrin isoform IVD, kit, nephelometry/turbidimetry Transferrin/transferrin isoform IVD, kit, nephelometry/turbidimetry Transferrin/transferrin isoform IVD, kit, nephelometry/turbidimetry Transferrin/transferrin isoform IVD, kit, nephelometry/turbidimetry Transferrin/transferrin isoform IVD, kit, nephelometry/turbidimetry Transferrin/transferrin isoform IVD, kit, nephelometry/turbidimetry Transferrin/transferrin isoform IVD, kit, nephelometry/turbidimetry Transferrin/transferrin isoform IVD, kit, nephelometry/turbidimetry

• Primary Device ID: 04015630919482
• NIH Device Record Key: 2220a0ff-3281-41a8-86d1-c1ca7ac82586
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Preciset sTfR
• Version Model Number: 12148331122
• Catalog Number: 12148331122
• 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
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04015630919482 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K003064

FDA Product Code

• DDG: TRANSFERRIN, ANTIGEN, ANTISERUM, CONTROL

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: 2023-09-13
• 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