5-PLASMA Bivalirudin Calibrator

Basic Information

• Brand Name: 5-PLASMA Bivalirudin Calibrator
• Primary DI: 05070002420392
• Version / Model: 5D-46905
• Catalog Number: 5D-46905
• Company Name: 5-Diagnostics Ltd
• Labeler DUNS: 487256547
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-04-02
• Public Version: 1
• Public Version Date: 2026-04-10
• Public Version Status: New
• Public Device Record Key: 3bcc9159-9ff2-49b7-ab06-7910575da956

Device Description

Human plasma-based calibrator material intended for calibration of bivalirudin measurements using anti-IIa clotting and chromogenic assay methods. The product consists of multiple calibration levels and is intended for in vitro diagnostic use by trained laboratory professionals.

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: Yes
• 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
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	862.1150	2

GMDN Terms

Code	Name	Definition	Implantable	Status
55995	Multiple coagulation factor IVD, calibrator	A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative determination of one or multiple coagulation factors, coagulation intermediates and/or their activated components in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05070002420392	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius