Creatine kinase 5401593190

GUDID 04015630926909

Roche Diagnostics GmbH

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

• Primary Device ID: 04015630926909
• NIH Device Record Key: c70936dd-4896-4ee2-aaf2-3326d015401b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Creatine kinase
• Version Model Number: 5401593190
• Catalog Number: 5401593190
• 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	04015630926909 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K951595

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

On-Brand Devices [Creatine kinase]

• 07613336121122: 08057460190
• 04015630926909: 5401593190