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 ID05055273218985
NIH Device Record Key8d9de463-c8c6-4980-9045-3817769c2491
Commercial Distribution StatusIn Commercial Distribution
Brand NameConcizuTrace™ ELISA
Version Model NumberCZM10591
Catalog NumberCZM10591
Company DUNS227530649
Company NameRANDOX LABORATORIES LIMITED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+442894451070
Emailtechnical.services@randox.com
Phone+442894451070
Emailtechnical.services@randox.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS105055273218985 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

SESNon-Factor Replacement Product Test System

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-06-09
Device Publish Date2025-05-30

Devices Manufactured by RANDOX LABORATORIES LIMITED

05055273218985 - ConcizuTrace™ ELISA2025-06-09The 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™ ELISA2025-06-09 The ConcizuTrace™ ELISA device is for use in determining the concentration of the drug, concizumab, in 3.2% citrated plasma fr
05055273210101 - Liquid Immunoassay Control – Level 1 (IA CONTROL 1)2025-04-01 The Liquid Immunoassay Control is intended for use with in vitro diagnostic assays for the quantitative determination of 25-OH V
05055273210118 - LIQUID IMMUNOASSAY CONTROL - LEVEL 2 (IA CONTROL 2)2025-04-01 The Liquid Immunoassay Control is intended for use with in vitro diagnostic assays for the quantitative determination of 25-OH V
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
05055273219814 - PTH CONTROL LEVEL 1 (PTH CONTROL 1)2025-04-01 The PTH Control Level 1 is intended for use with in vitro diagnostic immunoassays for the quantitative determination of Parathyr
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 12025-03-31 The Liquid Cardiac Controls are intended for use with in vitro diagnostic assays for the quantitative determination of CKMB, Hig

Trademark Results [ConcizuTrace]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CONCIZUTRACE
CONCIZUTRACE
79387857 not registered Live/Pending
Randox Laboratories Limited
2023-06-22

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