Dimension Vista® a1-Microglobulin Flex® reagent cartridge

Basic Information

• Brand Name: Dimension Vista® a1-Microglobulin Flex® reagent cartridge
• Primary DI: 00842768005978
• Version / Model: 10445882
• Catalog Number: K7010
• Company Name: Siemens Healthcare Diagnostics Products GmbH
• Labeler DUNS: 388240673
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2020-09-24
• Public Version: 2
• Public Version Date: 2021-11-18
• Public Version Status: Update
• Public Device Record Key: 747e227d-00f4-4ab7-b5e3-62761e0284c3

Device Description

For the quantitative measurement of a1-microglobulin in human urine on the Dimension Vista® System

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: 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
DCO	ALPHA-GLOBULIN, ANTIGEN, ANTISERUM, CONTROL	Immunology	866.5400	1

GMDN Terms

Code	Name	Definition	Implantable	Status
53923	Alpha-1-microglobulin IVD, kit, nephelometry/turbidimetry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of alpha-1-microglobulin in a clinical specimen, using a nephelometry/turbidimetry method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00842768005978	GS1
Unit of Use	00842768019852	GS1

Customer Contacts

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

Storage Conditions

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