Free Phenytoin Controls 20759023322

GUDID 04015630915828

Roche Diagnostics GmbH

Multiple therapeutic drugs/drugs of abuse IVD, control

• Primary Device ID: 04015630915828
• NIH Device Record Key: 8fdc8295-e96d-4699-96e0-be98ba0c1ba3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Free Phenytoin Controls
• Version Model Number: 20759023322
• Catalog Number: 20759023322
• 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: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04015630915828 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K954992

FDA Product Code

• MOJ: FLUORESCENCE POLARIZATION IMMUNOASSAY, DIPHENYLHYDANTOIN (FREE)

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: 2021-02-16
• Device Publish Date: 2021-02-08

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• 07613336183236 - PreciControl HBsAg II Auto Confirm: 2024-11-15
• 07613336234402 - navify® Lab Operations: 2024-11-05
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• 07613336217672 - Elecsys free PSA: 2024-11-01