Alere NT-proBNP for Alinity Calibrator Kit

Basic Information

• Brand Name: Alere NT-proBNP for Alinity Calibrator Kit
• Primary DI: 05055845400534
• Version / Model: 04S7902
• Catalog Number: 04S7902
• Company Name: AXIS-SHIELD DIAGNOSTICS LIMITED
• Labeler DUNS: 229062427
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-02-27
• Public Version: 1
• Public Version Date: 2025-03-07
• Public Version Status: New
• Public Device Record Key: be705e57-9306-4acb-ab8a-c047a696cb72

Device Description

The Alere NT-proBNP for Alinity i Calibrators are for the calibration of the Alinity i analyzer when used for the quantitative determination of N-terminal pro B-type natriuretic peptide (NT-proBNP) in human serum and plasma. For additional information, refer to the Alere NT-proBNP for Alinity i reagent package insert and the Alinity ci-series Operations Manual.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• 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
JIT	Calibrator, Secondary	Clinical Chemistry	862.1150	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47353	B-type natriuretic protein/N-terminal pro b-type natriuretic peptide 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 detection of B-type natriuretic protein (BNP) and/or N-terminal pro b-type natriuretic peptide (NT-proBNP) in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05055845400534	GS1

Customer Contacts

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