ConcizuTrace™ Sample Collection Kit CZM10596
GUDID 05055273218893
The Randox ConcizuTrace™ sample collection kit is used for the collection and transportation of blood samples, taken by a trained phlebotomist. The samples will be transported to a professional laboratory for testing using either the ConcizuTrace™ ELISA kit or Concizumab ELISA kit.
RANDOX LABORATORIES LIMITED
Venous blood collection kit IVD Venous blood collection kit IVD Venous blood collection kit IVD Venous blood collection kit IVD Venous blood collection kit IVD Venous blood collection kit IVD Venous blood collection kit IVD Venous blood collection kit IVD Venous blood collection kit IVD Venous blood collection kit IVD Venous blood collection kit IVD Venous blood collection kit IVD Venous blood collection kit IVD Venous blood collection kit IVD Venous blood collection kit IVD Venous blood collection kit IVD Venous blood collection kit IVD Venous blood collection kit IVD| Primary Device ID | 05055273218893 |
| NIH Device Record Key | d22b8000-6095-4582-bf30-9022207a3a75 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ConcizuTrace™ Sample Collection Kit |
| Version Model Number | CZM10596 |
| Catalog Number | CZM10596 |
| Company DUNS | 227530649 |
| Company Name | RANDOX LABORATORIES LIMITED |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 |
| concizutrace.support@randox.com | |
| Phone | +442894451070 |
| concizutrace.support@randox.com | |
| Phone | +442894451070 |
| concizutrace.support@randox.com | |
| Phone | +442894451070 |
| concizutrace.support@randox.com | |
| Phone | +442894451070 |
| concizutrace.support@randox.com | |
| Phone | +442894451070 |
| concizutrace.support@randox.com | |
| Phone | +442894451070 |
| concizutrace.support@randox.com | |
| Phone | +442894451070 |
| concizutrace.support@randox.com | |
| Phone | +442894451070 |
| concizutrace.support@randox.com | |
| Phone | +442894451070 |
| concizutrace.support@randox.com | |
| Phone | +442894451070 |
| concizutrace.support@randox.com | |
| Phone | +442894451070 |
| concizutrace.support@randox.com | |
| Phone | +442894451070 |
| concizutrace.support@randox.com | |
| Phone | +442894451070 |
| concizutrace.support@randox.com | |
| Phone | +442894451070 |
| concizutrace.support@randox.com | |
| Phone | +442894451070 |
| concizutrace.support@randox.com | |
| Phone | +442894451070 |
| concizutrace.support@randox.com | |
| Phone | +442894451070 |
| concizutrace.support@randox.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05055273218893 [Primary] |
FDA Product Code
| PQD | Blood Specimen Collection Convenience Kit (Excludes Hiv) |
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 | 2023-08-08 |
| Device Publish Date | 2023-07-31 |
Devices Manufactured by RANDOX LABORATORIES LIMITED
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| 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 |
| 05055273218725 - XANTHOCHROMIA POSITIVE CONTROL (XANTHOCHROMIA ) | 2023-12-29 The Xanthochromia Positive Control is intended for use with in vitro diagnostic assays for the quantitative determination of Bil |
| 05055273218732 - XANTHOCHROMIA NEGATIVE CONTROL (XANTHOCHROMIA ) | 2023-12-29 The Xanthochromia Negative Control is intended for use with in vitro diagnostic assays for the quantitative determination of Bil |
| 05055273218992 - PRE-ECLAMPSIA CONTROL LEVEL 3 | 2023-12-29 The Pre eclampsia Control Level 3 is intended for use with in vitro diagnostic assays for the quantitative determination of plac |
Trademark Results [ConcizuTrace]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CONCIZUTRACE 79387857 not registered Live/Pending |
Randox Laboratories Limited 2023-06-22 |
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