ConcizuTrace™ ELISA CZM10591

GUDID 05055273218985

The ConcizuTrace™ ELISA device is for use in determining the concentration of the drug, concizumab, in 3.2% citrated plasma from patients with Haemophilia A & B, with and without inhibitors, who are undergoing treatment with concizumab for routine prophylaxis of bleeding episodes. The device is a sandwich ELISA. The intended users are trained laboratory professionals.

RANDOX LABORATORIES LIMITED

Concizumab therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 05055273218985
• NIH Device Record Key: 8d9de463-c8c6-4980-9045-3817769c2491
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ConcizuTrace™ ELISA
• Version Model Number: CZM10591
• Catalog Number: CZM10591
• 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: false
• 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

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
• 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	05055273218985 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN240035

FDA Product Code

• SES: Non-Factor Replacement Product Test System

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: 2025-06-09
• Device Publish Date: 2025-05-30

Devices Manufactured by RANDOX LABORATORIES LIMITED

• 05055273218985 - ConcizuTrace™ ELISA: 2025-06-09The ConcizuTrace™ ELISA device is for use in determining the concentration of the drug, concizumab, in 3.2% citrated plasma from patients with Haemophilia A & B, with and without inhibitors, who are undergoing treatment with concizumab for routine prophylaxis of bleeding episodes. The device is a sandwich ELISA. The intended users are trained laboratory professionals.
• 05055273218985 - ConcizuTrace™ ELISA: 2025-06-09 The ConcizuTrace™ ELISA device is for use in determining the concentration of the drug, concizumab, in 3.2% citrated plasma fr
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• 05055273210125 - LIQUID IMMUNOASSAY CONTROL - LEVEL 3 (IA CONTROL 3): 2025-04-01 The Liquid Immunoassay Control is intended for use with in vitro diagnostic assays for the quantitative determination of 25-OH V
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• 05055273219821 - PTH CONTROL LEVEL 2 (PTH CONTROL 2): 2025-04-01 The PTH Control Level 2 is intended for use with in vitro diagnostic immunoassays for the quantitative determination of Parathyr
• 05055273219838 - PTH CONTROL LEVEL 3 (PTH CONTROL 3): 2025-04-01 The PTH Control Level 3 is intended for use with in vitro diagnostic immunoassays for the quantitative determination of Parathyr
• 05055273219043 - LIQUID CARDIAC CONTROL 1: 2025-03-31 The Liquid Cardiac Controls are intended for use with in vitro diagnostic assays for the quantitative determination of CKMB, Hig