D LDL/HDL CAL CH2673

GUDID 05055273201239

The device is intended for in vitro diagnostic use in the calibration of Randox HDL and LDL cholesterol clearance methods

RANDOX LABORATORIES LIMITED

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• Primary Device ID: 05055273201239
• NIH Device Record Key: d1ba9567-6039-4b2a-aa7c-d801f46e4761
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: D LDL/HDL CAL
• Version Model Number: CH2673
• Catalog Number: CH2673
• 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
• 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 Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Once reconstituted, the components are stable for 5 days at +2°C to +8°C and 4 weeks at –20°C when frozen once.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Once reconstituted, the components are stable for 5 days at +2°C to +8°C and 4 weeks at –20°C when frozen once.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Once reconstituted, the components are stable for 5 days at +2°C to +8°C and 4 weeks at –20°C when frozen once.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Once reconstituted, the components are stable for 5 days at +2°C to +8°C and 4 weeks at –20°C when frozen once.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Once reconstituted, the components are stable for 5 days at +2°C to +8°C and 4 weeks at –20°C when frozen once.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Once reconstituted, the components are stable for 5 days at +2°C to +8°C and 4 weeks at –20°C when frozen once.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Once reconstituted, the components are stable for 5 days at +2°C to +8°C and 4 weeks at –20°C when frozen once.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Once reconstituted, the components are stable for 5 days at +2°C to +8°C and 4 weeks at –20°C when frozen once.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Once reconstituted, the components are stable for 5 days at +2°C to +8°C and 4 weeks at –20°C when frozen once.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Once reconstituted, the components are stable for 5 days at +2°C to +8°C and 4 weeks at –20°C when frozen once.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Once reconstituted, the components are stable for 5 days at +2°C to +8°C and 4 weeks at –20°C when frozen once.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Once reconstituted, the components are stable for 5 days at +2°C to +8°C and 4 weeks at –20°C when frozen once.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Once reconstituted, the components are stable for 5 days at +2°C to +8°C and 4 weeks at –20°C when frozen once.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Once reconstituted, the components are stable for 5 days at +2°C to +8°C and 4 weeks at –20°C when frozen once.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Once reconstituted, the components are stable for 5 days at +2°C to +8°C and 4 weeks at –20°C when frozen once.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Once reconstituted, the components are stable for 5 days at +2°C to +8°C and 4 weeks at –20°C when frozen once.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Once reconstituted, the components are stable for 5 days at +2°C to +8°C and 4 weeks at –20°C when frozen once.

Device Identifiers

Device Issuing Agency	Device ID
GS1	05055273201239 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122126

FDA Product Code

• JIS: Calibrator, Primary

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

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