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

Devices Manufactured by Roche Diagnostics GmbH

• 07613336230367 - Elecsys Anti-HBs II: 2024-08-28
• 07613336217801 - Elecsys FSH: 2024-08-27
• 07613336218327 - Elecsys CA 125 II: 2024-08-21
• 07613336218464 - Elecsys Toxo IgM: 2024-08-21
• 04015630928941 - Homocysteine Calibrator Kit: 2024-08-20
• 04015630037025 - cobas b 123 Fluid Pack 400: 2024-08-07
• 04015630037032 - cobas b 123 Fluid Pack 700: 2024-08-07
• 04015630037049 - cobas b 123 Fluid Pack 200: 2024-08-07