Theophylline 20737917322

GUDID 04015630915910

Roche Diagnostics GmbH

Theophylline therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry

• Primary Device ID: 04015630915910
• NIH Device Record Key: e8334995-e26b-4623-981d-fc2f1c0b06da
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Theophylline
• Version Model Number: 20737917322
• Catalog Number: 20737917322
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04015630915910 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K951595

FDA Product Code

• LGS: FLUORESCENCE POLARIZATION IMMUNOASSAY, THEOPHYLLINE

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-10-12
• Device Publish Date: 2016-09-20

On-Brand Devices [Theophylline]

• 04015630997787: 4491025190
• 04015630915910: 20737917322