ConcizuTrace™ Sample Collection Kit

Basic Information

• Brand Name: ConcizuTrace™ Sample Collection Kit
• Primary DI: 05055273218893
• Version / Model: CZM10596
• Catalog Number: CZM10596
• Company Name: RANDOX LABORATORIES LIMITED
• Labeler DUNS: 227530649
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-07-31
• Public Version: 1
• Public Version Date: 2023-08-08
• Public Version Status: New
• Public Device Record Key: d22b8000-6095-4582-bf30-9022207a3a75

Device Description

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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PQD	Blood Specimen Collection Convenience Kit (Excludes Hiv)	Clinical Chemistry	862.1675	2

GMDN Terms

Code	Name	Definition	Implantable	Status
66838	Venous blood collection kit IVD	A collection of in vitro diagnostic devices and materials intended for use by a healthcare professional at the point-of-care for the collection of a venous blood specimen, for subsequent diagnostic testing or screening. The kit typically includes venous access needle with tubing and connector, a blood collection tube(s) [with or without additives (e.g., sodium citrate)], and additional items (e.g., tourniquet, pipette, gauze pads, alcohol pads, dressings and a container with a requisition form, for mailing to the laboratory). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05055273218893	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 4 – 25 Degrees Celsius