ONLINE TDM Methotrexate 09230815190

GUDID 07613336224823

Roche Diagnostics GmbH

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

• Primary Device ID: 07613336224823
• NIH Device Record Key: a77a73cf-7181-49a3-8d5b-1f9308a39f9e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ONLINE TDM Methotrexate
• Version Model Number: 09230815190
• Catalog Number: 09230815190
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613336224823 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233454

FDA Product Code

• LAO: Enzyme immunoassay, methotrexate

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: 2024-04-02
• Device Publish Date: 2024-03-25

On-Brand Devices [ONLINE TDM Methotrexate ]

• 07613336224823: 09230815190
• 07613336224816: 09230785190