Alpha2-Macroglobulin CAL KIT

Basic Information

• Brand Name: Alpha2-Macroglobulin CAL KIT
• Primary DI: 05415168004770
• Version / Model: 08240400190
• Catalog Number: 08240400190
• Company Name: Diagam
• Labeler DUNS: 374384030
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-01-08
• Public Version: 1
• Public Version Date: 2020-01-16
• Public Version Status: New
• Public Device Record Key: 39ebe769-7185-4bb5-b3f1-dff2acff84c4

Device Description

Calibration of Alpha2-Macroglobulin assay on cobas c501/502 systems.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• 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: Yes
• 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
JIS	Calibrator, Primary	Clinical Chemistry	862.1150	2

GMDN Terms

Code	Name	Definition	Implantable	Status
41260	Alpha-2-macroglobulin IVD, calibrator	A material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement of alpha-2-macroglobulin in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05415168004770	GS1

Storage Conditions

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