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 |
Phone | +442894451070 |
technical.services@randox.com | |
Phone | +442894451070 |
technical.services@randox.com |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 05055273218985 [Primary] |
SES | Non-Factor Replacement Product Test System |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2025-06-09 |
Device Publish Date | 2025-05-30 |
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 |
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 1 | 2025-03-31 The Liquid Cardiac Controls are intended for use with in vitro diagnostic assays for the quantitative determination of CKMB, Hig |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() CONCIZUTRACE 79387857 not registered Live/Pending |
Randox Laboratories Limited 2023-06-22 |