XANTHOCHROMIA POSITIVE CONTROL (XANTHOCHROMIA )

GUDID 05055273218725

The Xanthochromia Positive Control is intended for use with in vitro diagnostic assays for the quantitative determination of Bilirubin and Oxyhaemoglobin for monitoring of Subarachnoid-haemorrhage testing in Cerebrospinal Fluid (CSF) for Xanthochromia using a spectrophotometer. Xanthochromia Positive Control is unassayed, without target values and is suitable for use on various UV spectrophotometer analysers. Xanthochromia Positive Control is for use by trained laboratory professionals and can be used in determining the precision of testing systems and in identifying sources of variation.

RANDOX LABORATORIES LIMITED

Multiple-type clinical chemistry analyte profile IVD, control

• Primary Device ID: 05055273218725
• NIH Device Record Key: 93663247-6b61-41b1-b165-b4be1cdbc7ea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: XANTHOCHROMIA POSITIVE CONTROL (XANTHOCHROMIA )
• Version Model Number: XN10505
• Company DUNS: 227530649
• Company Name: RANDOX LABORATORIES LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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
• 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
• 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 Humidity: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Humidity: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Humidity: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Humidity: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Humidity: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Humidity: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Humidity: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Humidity: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Humidity: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Humidity: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Humidity: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Humidity: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Humidity: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Humidity: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Humidity: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Humidity: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Humidity: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05055273218725 [Primary]

FDA Product Code

• OHQ: Multi-Analyte Controls Unassayed

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-12-29
• Device Publish Date: 2023-12-21

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