ONLINE TDM Tobramycin 08253161190

GUDID 07613336147948

Roche Diagnostics GmbH

Tobramycin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 07613336147948
• NIH Device Record Key: 44417ce3-44b1-4f72-aee6-99339e435f69
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ONLINE TDM Tobramycin
• Version Model Number: 08253161190
• Catalog Number: 08253161190
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613336147948 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060853

FDA Product Code

• KLB: RADIOIMMUNOASSAY, TOBRAMYCIN

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

• 07613336227763 - Sodium electrode: 2025-03-13
• 07613336227770 - Potassium electrode: 2025-03-13
• 07613336227787 - Chloride electrode: 2025-03-13
• 07613336227794 - Reference electrode: 2025-03-13
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• 07613336228487 - Elecsys Anti-HBc II: 2025-02-27
• 07613336228500 - Elecsys HIV Duo: 2025-02-27
• 07613336183212 - PreciControl HIV Gen II: 2025-02-27