Cardiac CReactive Protein Latex High Sensitive 4628918190

GUDID 04015630921508

Roche Diagnostics GmbH

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

• Primary Device ID: 04015630921508
• NIH Device Record Key: f7bdaf5c-d2a3-4cd7-96a3-685b88a5774b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cardiac CReactive Protein Latex High Sensitive
• Version Model Number: 4628918190
• Catalog Number: 4628918190
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04015630921508 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K053603

FDA Product Code

• NQD: CARDIAC C-REACTIVE PROTEIN, ANTIGEN, ANTISERUM, AND CONTROL

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2022-06-10
• Device Publish Date: 2016-09-20

On-Brand Devices [Cardiac CReactive Protein Latex High Sensitive]

• 04015630928774: 5950864190
• 04015630926916: 5401607190
• 04015630921508: 4628918190