Tina-quant CReactive Protein IV 07876424190

GUDID 04015630946846

Roche Diagnostics GmbH

C-reactive protein (CRP) IVD, kit, nephelometry/turbidimetry

• Primary Device ID: 04015630946846
• NIH Device Record Key: c8915994-9b8f-42e8-a7b6-4bd94b158aaf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tina-quant CReactive Protein IV
• Version Model Number: 07876424190
• Catalog Number: 07876424190
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04015630946846 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192072

FDA Product Code

• DCN: SYSTEM, TEST, C-REACTIVE PROTEIN

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: 2020-05-21
• Device Publish Date: 2020-05-13

On-Brand Devices [Tina-quant CReactive Protein IV]

• 04015630946853: 07876432190
• 04015630946846: 07876424190
• 04015630946839: 07876033190