QuikRead go® CRP Control set 145217

GUDID 06438115000112

QuikRead go® CRP Control Set is intended for use as assayed quality-control material for monitoring the performance of the quantitative QuikRead go CR

Orion Diagnostica Oy

C-reactive protein (CRP) IVD, control

• Primary Device ID: 06438115000112
• NIH Device Record Key: 45255bb0-aff9-4737-bfa3-49e79f304003
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QuikRead go® CRP Control set
• Version Model Number: 145217
• Catalog Number: 145217
• 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: +358104261
• Email: product.support@oriondiagnosti
• 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	06438115000112 [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

Devices Manufactured by Orion Diagnostica Oy

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• 06438115000020 - Uricult® CLED/MacConkey: 2020-02-06 A dip slide culture method for the detection of bacteriuria and the presumptive identification of uropathogens.
• 06438115000037 - Uricult CLED/EMB: 2020-02-06 A dip slide culture method for the detection of bacteriuria and the presumptive identification of uropathogens.
• 06438115000044 - Uricult® Trio: 2020-02-06 A dip slide culture method for diagnosing urinary tract infections by demonstrating microbes in urine.
• 06438115000198 - QuikRead go® Instrument: 2019-03-11 QuikRead go® instrument has been designed to measure quantitative test results from patient samples using QuikRead go® reagent
• 06438115000082 - UniQ® PINP RIA: 2018-07-06 UniQ® PINP RIA is a quantitative radioimmunoassay designed for the measurement of the concentration of intact aminoterminal pro
• 06438115000099 - QuikRead go® CRP: 2018-07-06 QuikRead go® CRP test is an immunoturbidimetric assay for the in vitro quantitative determination of C-reactive protein (CRP).