Cocaine 08057508190

GUDID 07613336121153

Roche Diagnostics GmbH

Cocaine/cocaine metabolite IVD, reagent

• Primary Device ID: 07613336121153
• NIH Device Record Key: 8d1d47d1-780d-4173-9e8d-cdac41422329
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cocaine
• Version Model Number: 08057508190
• Catalog Number: 08057508190
• 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	07613336121153 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K023281

FDA Product Code

• DIO: Enzyme immunoassay, cocaine and cocaine metabolites

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: 2020-03-16
• Device Publish Date: 2020-03-06

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• 07613336217665 - Elecsys Total PSA: 2024-11-01