Creatine Kinase 08057460190

GUDID 07613336121122

Roche Diagnostics GmbH

Total creatine kinase (CK) IVD, kit, enzyme spectrophotometry

• Primary Device ID: 07613336121122
• NIH Device Record Key: 2bc8bcaa-8d23-4104-b7af-e9be35e6391e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Creatine Kinase
• Version Model Number: 08057460190
• Catalog Number: 08057460190
• 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	07613336121122 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160570

FDA Product Code

• JHS: DIFFERENTIAL RATE KINETIC METHOD, CPK OR ISOENZYMES

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: 2020-03-13
• Device Publish Date: 2020-03-05

On-Brand Devices [Creatine Kinase]

• 07613336121122: 08057460190
• 04015630926909: 5401593190