5-PLASMA Bivalirudin AMR Verification Kit

Basic Information

• Brand Name: 5-PLASMA Bivalirudin AMR Verification Kit
• Primary DI: 05070002420378
• Version / Model: 5D-45905
• Catalog Number: 5D-45905
• Company Name: 5-Diagnostics Ltd
• Labeler DUNS: 487256547
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-04-20
• Public Version: 1
• Public Version Date: 2026-04-28
• Public Version Status: New
• Public Device Record Key: 86a27a50-184d-40a6-8018-894d4d5d2d11

Device Description

The 5-PLASMA Bivalirudin AMR Verification Kit is an in vitro diagnostic reagent kit intended for the verification of the Analytical Measurement Range (AMR) of assays used to quantify bivalirudin activity or concentration in human plasma. The kit consists of five levels of plasma-based materials containing defined concentrations of bivalirudin, covering the clinically relevant measurement range of the associated assay. The kit is designed for laboratory use to verify that a coagulation analyzer or assay method performs accurately and linearly across its claimed analytical measuring range for bivalirudin. It is not intended for direct diagnostic use or patient result reporting.

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
JIT	Calibrator, Secondary	Clinical Chemistry	862.1150	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60687	Direct thrombin inhibitor therapeutic drug monitoring IVD, calibrator	A material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement and/or therapeutic monitoring of a direct thrombin inhibitor oral anticoagulant (e.g., dabigatran, argatroban, hirudin) in a clinical specimen, by determining its ability to inhibit the activity of activated coagulation factor IIa, also referred to as thrombin.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05070002420378	GS1

Customer Contacts

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

Storage Conditions

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