CRP CP1423

GUDID 05055273201642

The device is a latex agglutination slide test intended for qualitative and semi-quantitative in vitro diagnostic determination of C-Reactive Protein

RANDOX LABORATORIES LIMITED

C-reactive protein (CRP) IVD, reagent

• Primary Device ID: 05055273201642
• NIH Device Record Key: bfed086f-e6a7-4d80-9d12-e6668adddfe2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CRP
• Version Model Number: CP1423
• Catalog Number: CP1423
• 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

• Special Storage Condition, Specify: Between 0 and 0 *Must reach room temperature before use. Do not freeze any of the reagents.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Must reach room temperature before use. Do not freeze any of the reagents.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Must reach room temperature before use. Do not freeze any of the reagents.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Must reach room temperature before use. Do not freeze any of the reagents.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Must reach room temperature before use. Do not freeze any of the reagents.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Must reach room temperature before use. Do not freeze any of the reagents.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Must reach room temperature before use. Do not freeze any of the reagents.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05055273201642 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K954447

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 [CRP]

• 05055273201833: The CRP test system is intended for the quantitative in vitro determination of CRP concentration
• 05055273201826: The CRP test system is intended for the quantitative in vitro determination of CRP concentration
• 05055273201819: The device is intended for the quantitative in vitro diagnostic determination of C-Reactive Prot
• 05055273201765: The CRP test system is intended for the quantitative in vitro determination of CRP concentration
• 05055273201758: The XCRP method used on the Dimension clinical chemistry system is an in vitro diagnostic test i
• 05055273201741: The device is a latex agglutination slide test intended for qualitative and semi-quantitative in
• 05055273201734: The device is intended for the quantitative in vitro diagnostic determination of C-Reactive Prot
• 05055273201642: The device is a latex agglutination slide test intended for qualitative and semi-quantitative in