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

High-density lipoprotein (HDL) cholesterol IVD, calibrator

• 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

Devices Manufactured by RANDOX LABORATORIES LIMITED

• 05055273220018 - PlaySafe™: 2024-10-09 The PlaySafe kit is intended for use in the collection of a urine sample for laboratory analysis of nine sexually transmitted in
• 05055273216752 - Evidence MultiSTAT DOA Urine MultiPlex: 2024-09-24 The Evidence MultiSTAT DOA Urine MultiPlex is intended for use with the Evidence MultiSTAT. The Evidence MultiSTAT is an analyze
• 05055273214970 - Evidence MultiSTAT: 2024-09-23 The Evidence MultiSTAT is a benchtop, fully automated, immunoassay analyser that has been designed and developed to be operated
• 05055273219951 - ESSENTIAL PACKAGE SAMPLE COLLECTION KIT (USA): 2024-02-07 The Blood Sample Collection Kit is intended for use in the collection and transport of a blood sample, taken by a trained phlebo
• 05055273219968 - EXTENDED PACKAGE SAMPLE COLLECTION KIT (USA): 2024-02-07 The Blood Sample Collection Kit is intended for use in the collection and transport of a blood sample, taken by a trained phlebo
• 05055273219999 - EXTENDED PACKAGE SAMPLE COLLECTION KIT (USA U60): 2024-02-07 The Blood Sample Collection Kit is intended for use in the collection and transport of a blood sample, taken by a trained phlebo
• 05055273218480 - BNP CONTROLS FOR BECKMAN (BNP CONTROL): 2023-12-29 The BNP Controls for Beckman (CQ10520) are intended for use with in vitro diagnostic assays for the quantitative determination o
• 05055273218497 - BNP CONTROLS FOR ABBOTT (BNP CONTROL): 2023-12-29 The BNP Controls for Abbott (CQ10521) are intended for use with in vitro diagnostic assays for the quantitative determination of