frCRP CP3849

GUDID 05055273201789

The CRP test system is intended for the quantitative in vitro determination of C-Reactive Protein (CRP) concentration in serum or plasma.

RANDOX LABORATORIES LIMITED

C-reactive protein (CRP) IVD, reagent C-reactive protein (CRP) IVD, reagent C-reactive protein (CRP) IVD, reagent C-reactive protein (CRP) IVD, reagent C-reactive protein (CRP) IVD, reagent C-reactive protein (CRP) IVD, reagent C-reactive protein (CRP) IVD, reagent

• Primary Device ID: 05055273201789
• NIH Device Record Key: 3307678f-891b-45c1-ab42-f587408f0af6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: frCRP
• Version Model Number: CP3849
• Catalog Number: CP3849
• Company DUNS: 227530649
• Company Name: RANDOX LABORATORIES LIMITED
• 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: +442894451070
• Email: technical.services@randox.com
• Phone: +442894451070
• Email: technical.services@randox.com
• Phone: +442894451070
• Email: technical.services@randox.com
• Phone: +442894451070
• Email: technical.services@randox.com
• Phone: +442894451070
• Email: technical.services@randox.com
• Phone: +442894451070
• Email: technical.services@randox.com
• Phone: +442894451070
• Email: technical.services@randox.com

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	05055273201789 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K001009

FDA Product Code

• DCK: 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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-16

On-Brand Devices [frCRP]

• 05055273201796: The CRP test system is intended for the quantitative in vitro determination of C-Reactive Protei
• 05055273201789: The CRP test system is intended for the quantitative in vitro determination of C-Reactive Protei
• 05055273201772: The CRP test system is intended for the quantitative in vitro determination of C-Reactive Protei