QuikRead go® CRP Verification set 145216

GUDID 06438115000105

QuikRead go® CRP Verification Set is designed to be used for calibration verification and for method validation of the QuikRead go® CRP system. It is

Orion Diagnostica Oy

C-reactive protein (CRP) IVD, control

• Primary Device ID: 06438115000105
• NIH Device Record Key: e6f8cdc1-cff7-4d3b-b176-32af630bece4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QuikRead go® CRP Verification set
• Version Model Number: 145216
• Catalog Number: 145216
• Company DUNS: 401656868
• Company Name: Orion Diagnostica Oy
• 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: true
• 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

Customer Support Contacts

• Phone: +358103093000
• Email: product.support@aidian.eu
• Phone: +358103093000
• Email: product.support@aidian.eu
• Phone: +358103093000
• Email: product.support@aidian.eu
• Phone: +358103093000
• Email: product.support@aidian.eu
• Phone: +358103093000
• Email: product.support@aidian.eu
• Phone: +358103093000
• Email: product.support@aidian.eu

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	06438115000105 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142993

FDA Product Code

• JJX: Single (Specified) Analyte Controls (Assayed And Unassayed)

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: 2018-07-06
• Device Publish Date: 2016-06-01

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